[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,688,0,25,[9,47,79,103,125,153,178,202,226,251,275,300,331,350,372,388,415,443,465,483,505,525,551,580,606],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053503","pragmatic-trial-of-messaging-to-providers-about-treatment-of-heart-failure-at-inova-100053503",false,"NCT05433220","PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure at Inova","PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure (PROMPT-HF) at Inova","PROMPTHF-Inova","Inclusion Criteria:\n\n* Age\\>18 Years\n* Seen by a Cardiologist in an Inova clinic or Inova hospital setting\n* Left Ventricular Ejection Fraction ≤40%\n\nExclusion Criteria:\n\n* Opted out of EHR-based research\n* Hospice care\n* Already receiving maximally titrated doses of each of the four classes of evidence- based HFrEF medical therapy\n* Prior heart transplant","ALL","18 Years",{"count":21,"type":22},5000,"ESTIMATED","INTERVENTIONAL",[25],"NA","A randomized, single-blind intervention trial to test the comparative effectiveness of an electronic health record best practice advisory system that informs clinicians of guideline-indicated and FDA-approved heart failure medications currently not prescribed to their patients with heart failure versus usual care (no alert and how things are done currently). The purpose of the alert is to stimulate appropriate medication prescription for patients with heart failure and a reduced ejection fraction. This will be done across outpatient Inova clinics and at the five Inova hospitals.",[28],"Heart Failure",[28,30,31,32,33],"GDMT","NYHA","HFrEF","Implementation","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2022-08-25",{"date":42,"type":22},"2027-08-25",{"name":44,"class":45},"Inova Health Care Services","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100053687","phase-2-study-to-evaluate-safety-tolerability-and-drug-levels-of-bms-986435myk-224-in-participants-with-heart-failure-with-preserved-ejection-fraction-hfpef-100053687","NCT06122779","Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435\u002FMYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)","A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435\u002FMYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)","AURORA-HFpEF","Inclusion Criteria\n\n\\- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability.\n\nExclusion Criteria\n\n* Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative\u002Fstorage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","40 Years","85 Years",{"count":58,"type":22},208,[60],"PHASE2","The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435\u002FMYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).",[28],[64,65,66,67,68,69],"BMS-986435","MYK-224","Pharmacokinetics","Pharmacodynamics","Safety","HFpEF",{"date":37,"type":38},{"date":72,"type":38},"2023-11-07",{"date":74,"type":22},"2026-12-14",{"name":76,"class":77},"Bristol-Myers Squibb","INDUSTRY",117,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100053407","phase-2-efficacy-safety-and-pharmacokinetics-of-vericiguat-in-pediatric-participants-with-heart-failure-due-to-left-ventricular-systolic-dysfunction-mk-1242-036-100053407","NCT05714085","Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)","A Phase 2\u002F3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)","Inclusion Criteria:\n\n* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.\n* Has biventricular physiology with a morphologic systemic left ventricle.\n* Is currently receiving stable medical therapy for HF.\n* Has left ventricular ejection fraction (LVEF) \\\u003C45% assessed within 3 months before randomization.\n* Is of any sex\u002Fgender, from \\>28 days to \\\u003C18 years of age inclusive. Must weigh ≥3 kg to participate.\n* Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.\n* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period\n\nExclusion Criteria:\n\n* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and\u002For IV vasodilator, or recent IV diuretic.\n* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.\n* Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.\n* Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.\n* Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.\n* Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.\n* Has unoperated or residual hemodynamically significant congenital cardiac malformations.\n* Has hypertrophic or restrictive cardiomyopathy.\n* Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.\n* Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.\n* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease\n* Has severe pulmonary hypertension.\n* Requires continuous home oxygen for significant pulmonary disease and\u002For has known interstitial lung disease.\n* Has severe chronic kidney disease.\n* Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.\n* Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.\n* Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation\n* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.\n* Has received a COVID-19 vaccination within 1 week before randomization.","29 Days","17 Years",{"count":89,"type":22},342,[60,91],"PHASE3","This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.",[28,94],"Left Ventricular Systolic Dysfunction",{"date":37,"type":38},{"date":97,"type":38},"2023-05-31",{"date":99,"type":22},"2032-04-15",{"name":101,"class":77},"Merck Sharp & Dohme LLC",107,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":4},"100053262","advancing-clinical-heart-failure-outcomes-leveraging-defibrillation-lead-implant-system-for-left-bundle-branch-area-pacing-100053262","NCT07526896","Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing","ACHIEVED LBBAP","Inclusion Criteria:\n\n* Subject meets current ACC\u002FAHA\u002FHRS guidelines for implantation of a CRT-D device.\n* Subject has documented LVEF ≤ 35% within 60 days of enrollment.\n* Subject meets the criteria for presence of Strauss-defined LBBB.\n* Subject meets NYHA classification II or III.\n* Subject is willing and able to provide written consent.\n* Subject is at least 18 years of age at the time of consent.\n* Subject is geographically stable and willing and able to complete study procedures, including follow-up visits.\n* The subject's medical records must be accessible by the enrolling site over the follow-up period.\n\nExclusion Criteria:\n\n* Subject has documented myocardial infarction before enrollment.\n* Subject has non-LBBB conduction patterns such as Right Bundle Branch Block (RBBB) or non-specific IVCD.\n* Subject has 2nd or 3rd degree AV block.\n* Subject has persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL).\n* Subject has intrinsic (non-paced) QRS duration ≤ 120ms.\n* Subject with previous or existing pacemaker (including transvenous and transcatheter pacing system), Implantable Cardioverter Defibrillator (ICD, transvenous) or CRT-D (transvenous) device or leads.\n* Subject has contraindications for screw-in transvenous lead placement (e.g., mechanical right heart valve).\n* Subject underwent valve surgery within 90 days prior to enrollment.\n* Subject is unable or unwilling to undergo baseline CMR imaging, if previously collected CMR images are unavailable or do not meet minimum acceptable criteria.\n* Subject is post-heart transplantation or is actively listed on the transplantation list.\n* Subject is implanted with a left ventricular assist device (LVAD).\n* Subject has severe renal disease.\n* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure.\n* Subject has complex and uncorrected congenital heart disease.\n* Subject has life expectancy of less than 12 months.\n* Subject is pregnant or breastfeeding.\n* Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.",{"count":111,"type":22},110,[25],"This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator (CRT-D). This combined therapy is known as Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) and will be compared to LBBAP therapy over sequential 6-month periods in CRT-indicated patients with LBBB. Primary and secondary outcomes are echocardiographic changes. Exploratory assessments will include NT-proBNP and subject-reported quality of life (KCCQ). An observational treatment arm will include subjects who have not been randomized due to unsuccessful implant for real-world observational analysis",[28,115],"Systolic Bundle Branch Block, Left","NOT_YET_RECRUITING","2026-07-09",{"date":37,"type":38},{"date":120,"type":22},"2026-08",{"date":122,"type":22},"2029-09",{"name":124,"class":77},"Medtronic Cardiac Rhythm and Heart Failure",{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100645276","evalutation-of-a-hybrid-care-pathway-with-remote-monitoring-for-heart-failure-100645276","NCT07680634","Evalutation of a Hybrid Care Pathway With Remote MONitoring for Heart Failure","HARMONY-HF","Inclusion Criteria:\n\n* Adults (at least 18 years or older)\n* Diagnosed with heart failure according the prevailling ESC guideline\n* Treatment at the outpatient clinic at one of the seven participating hospitals\n* Sufficient digital literacy and adequate Dutch language proficiency by the patient or throught the informal caregiver.\n\nExclusion Criteria:\n\n* Inability or unwillingness to participate in home telemonitoring\n* Patients with end-stage heart failure or other terminal conditions",{"count":133,"type":22},6000,"OBSERVATIONAL","Heart failure is a long-term condition in which the heart cannot pump blood as well as it should. People with heart failure often need to be admitted to hospital when their symptoms suddenly get worse, which affects their quality of life and places a heavy burden on the healthcare system.\n\nIn recent years, hospitals have started using home telemonitoring, in which patients measure values such as their weight, blood pressure, heart rate, and symptoms at home every day. These measurements are sent to a Medical Service Center (MSC), who can step in quickly when early warning signs appear - often before the patient feels seriously unwell.\n\nThe HARMONY-HF study looks at how well this hybrid care pathway works in everyday practice. The researchers will compare heart failure patients who take part in the home telemonitoring programme with patients who receive usual care without telemonitoring, across seven hospitals in the Netherlands. Because all care is part of routine treatment, patients are not asked to do anything extra for the study; the researchers use information that is already collected during normal care.\n\nThe main goal is to find out whether patients in the telemonitoring programme spend more days at home and out of the hospital. The study also looks at survival, hospital admissions, quality of life, and the use of recommended heart failure medication. The findings will help determine whether this approach should be offered more widely.",[28],[138,139,140,141,142],"heart failure","home telemonitoring systems","remote monitoring","hybrid care pathway","observational cohort study","2026-07-01",{"date":145,"type":38},"2026-07-02",{"date":147,"type":38},"2023-05-01",{"date":149,"type":22},"2031-06",{"name":151,"class":45},"St. Antonius Hospital",7,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":163,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":46},"100632638","phase-1-safety-and-efficacy-of-second-infusion-of-fap-icdc-in-end-stage-dilated-cardiomyopathy-100632638","NCT07516288","Safety and Efficacy of Second Infusion of FAP iCDC in End-stage Dilated Cardiomyopathy","Safety and Efficacy of Second Infusion of Autologous Immunosuppressive CAR-DC Targeting FAP in the Treatment of End-stage Dilated Cardiomyopathy","Inclusion Criteria:\n\n* ≥18 years and ≤75 years of age, with a confirmed diagnosis of dilated cardiomyopathy.\n* Patients who previously received a single infusion of immunosuppressive CAR-DC (iCDC) therapy and, at 6 months after the first treatment, failed to maintain improvement in cardiac function, with cardiac function declining to baseline levels prior to treatment. These patients should have persistent heart failure symptoms that cannot be adequately improved, with left ventricular ejection fraction (LVEF) \\\u003C35%, New York Heart Association (NYHA) functional class III-IV, and INTERMACS profile 3-6.\n* Able to verbally confirm understanding of the risks, benefits, and alternative treatment options of the second administration of iCDC therapy, and willing to participate in the study. The participant or his\u002Fher legal representative must provide written informed consent prior to enrollment.\n* Hematocrit \\>30%, lymphocyte count \\>0.5 × 10⁹\u002FL, and platelet count \\>60 × 10⁹\u002FL.\n\nExclusion Criteria:\n\n* Severe renal failure or requirement for renal dialysis, or serum creatinine \\>2.5 mg\u002FdL.\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 5.0 times the upper limit of normal (ULN), or total bilirubin \\>3 mg\u002FdL.\n* Presence of active infections at screening, including: Active hepatitis B infection with hepatitis B virus DNA \\>1000 copies\u002FmL by PCR testing; Hepatitis C virus infection; Syphilis; Human immunodeficiency virus (HIV) infection; Uncontrolled systemic fungal, bacterial, viral, or other pathogenic infections.\n* Severe hemodynamic instability (e.g., shock).\n* Known contraindications to the investigational product or study-related procedures.","75 Years",{"count":162,"type":22},5,[164],"PHASE1","This study aims to evaluate the safety and preliminary efficacy of a second administration of fibroblast activation protein (FAP)-targeted immunosuppressive chimeric antigen receptor dendritic cells (CAR-DC) in patients with end-stage dilated cardiomyopathy.\n\nPrevious clinical research has shown that single-dose CAR-DC therapy is safe and may provide clinical benefit. However, some patients experience recurrent worsening of heart function after initial treatment. This study will assess whether a second CAR-DC infusion is safe and whether it can further improve cardiac function in this patient population.",[167,28],"Dilated Cardiomyopathy (DCM)",[169,170],"end-stage dilated cardiomyopathy","FAP immunosuppressive CAR-DC",{"date":145,"type":38},{"date":173,"type":38},"2026-05-11",{"date":175,"type":22},"2027-12-31",{"name":177,"class":45},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":198,"leadSponsor":200,"locationsCount":46},"100570237","phase-4-sacubitril-valsartan-in-patients-with-heart-failure-with-reduced-ejection-fraction-from-rural-tanzania-100570237","NCT06704633","Sacubitril-valsartan in Patients With Heart Failure With Reduced Ejection Fraction From Rural Tanzania","Health Status After Switching Angiotensin-converting Enzyme Inhibitors or Angiotensin Receptor Blockers to Sacubitril-valsartan in Patients With Heart Failure With Reduced Ejection Fraction From Rural Tanzania: An Interventional Study","Inclusion criteria\n\n* Symptomatic heart failure NYHA class II-IV and\n* Left ventricular ejection fraction (LVEF) ≤40% and\n* Treatment with an ACE Inhibitor or an ARB, beta-blocker, and spironolactone in recommended dosages for at least 3 months, and\n* Adherence to this therapy of at least 80%.\n\nExclusion criteria\n\n* Pregnancy\n* Systolic blood pressure of less than 95 mmHg,\n* eGFR below 30 ml per minute per 1.73 m2 of body-surface area\n* Serum potassium level of more than 5.4 mmol per liter\n* History of angioedema\n* Unacceptable side effects prior during receipt of ACE inhibitors or ARBs\n* Inability to sign an informed consent form.",{"count":186,"type":22},298,[188],"PHASE4","Angiotensin-neprilysin inhibitors (ARNI) are beneficial in patients with heart failure with reduced ejection fraction. No study evaluating ARNI has been conducted in sub-Saharan Africa (except South Africa) yet, where heart failure is a major health problem. Before implementing ARNI in Tanzania, a study evaluating the benefit and safety of ARNI in Africans is needed. The aim of this interventional pre-post study is to evaluate the health status of symptomatic patients with heart failure with reduced ejection fraction who are under a chronic heart failure therapy, before and after switching angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) to ARNI. Participants will be recruited at the Heart and Lung Clinic of the St Francis Regional Referral Hospital in Ifakara in rural Tanzania during a study period of 30 months, including 10 months of follow-up. A total of 298 participants will be included. The investigators hypothesize that health status, expressed by the Kansas City Cardiomyopathy Questionnaire summary score and 6-minute walking test, will improve after switching from ACE-inhibitors or ARB to ARNI. In Tanzania, sacubitril\u002Fvalsartan is registered under the name Uperio®.",[28],[192,193,32,194],"Sacubitril-valsartan","Heart failure with reduced ejection fraction,","KCCQ","2026-06-30",{"date":145,"type":38},{"date":195,"type":38},{"date":199,"type":22},"2028-11-30",{"name":201,"class":45},"Martin Rohacek",{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":209,"sex":18,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":214,"conditions":215,"keywords":216,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":46},"100641560","withings-hfrn-retrospective-study-100641560","NCT07654491","Withings HFRN Retrospective Study","Validation of the Withings Heart Function Risk Notification (HFRN)","Inclusion Criteria:\n\n* Users of commercially purchased, consumer-grade Withings smart scales\n* A source of step counts synced into the Withings ecosystem (a Withings activity tracker, a smartphone, or a third-party activity tracker)\n* Claims linkage available, enabling heart-failure ground-truth ascertainment\n* Age \\>= 45 years\n* At least one 13-week quarter in which at least one of the three quarterly features (mean BMI, standard deviation of body-water percent, 90th-percentile daily steps) can be computed\n\nExclusion Criteria:\n\n* Users for whom heart-failure status cannot be determined from claims (unknown label; e.g. controls with \\\u003C 2 years of continuous enrollment)\n* Users with no usable measurement after per-reading plausibility screening\n* Users without an individual Withings account (shared accounts excluded to prevent data contamination)",true,"45 Years","120 Years",{"count":213,"type":22},9000,"This is a fully decentralized retrospective, non-interventional study evaluating the diagnostic performance of the Withings Heart Function Risk Notification (HFRN), a software-only medical device (SaMD)",[28],[217],"mhealth","2026-06-29",{"date":143,"type":38},{"date":221,"type":22},"2026-06",{"date":223,"type":22},"2026-09",{"name":225,"class":77},"Withings",{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":240,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":46},"100590300","phase-2-18f-mfbg-imaging-for-myocardial-sympathetic-innervation-100590300","NCT06965621","18F-mFBG Imaging for Myocardial Sympathetic Innervation","An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With Heart Failure and Implantable Cardioverter-Defibrillators","Inclusion Criteria:\n\n* Stable heart failure from ischemic cardiomyopathy, LVEF \\\u003C or = 35%, ICD implantation for at least 12 months\n\nExclusion Criteria:\n\n* Unstable coronary artery disease, no ICD implantation",{"count":234,"type":22},20,[60],"This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation. The study will examine a group of stable patients with heart failure (HF) from ischemic cardiomyopathy. All subjects will have left ventricular ejection fraction (LVEF) ≤35% and implantable cardioverter-defibrillators (ICD). The primary objectives of the study will be to:\n\n* document the degree to which 18F-mFBG uptake in the heart is reduced (compared to historical controls)\n* characterize the distribution of regional abnormalities in relation to findings on rest\u002Fstress positron-emission tomography (PET) myocardial perfusion imaging (MPI)\n* determine if there are global and\u002For regional differences in myocardial sympathetic innervation between subjects who have and have not experienced an appropriate ICD activation within the previous 12 months Effectiveness of 18F-mFBG will be judged in relation to historical experience with other nuclear imaging agents for cardiac sympathetic innervation imaging such as a 123I-meta-iodobenzylguanidine (mIBG) and 11C-hydroxyephedrine (HED).\n\nSafety data will be collected to identify adverse events \\[AEs\\] and serious adverse events \\[SAEs\\] and characterize the safety profile of 18F-mFBG.",[28,238,239],"Ischemic Cardiomyopathy","ICD Patients",[241,242,243],"Myocardial sympathetic innervation","PET myocardial imaging","18F-mFBG",{"date":143,"type":38},{"date":246,"type":38},"2025-11-05",{"date":248,"type":22},"2026-12-30",{"name":250,"class":77},"Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)",{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":274},"100539105","raft---pace-ablate-100539105","NCT06299514","RAFT - Pace &Ablate","Resynchronization for Ambulatory Heart Failure Trial in Patients With Chronic Atrial Fibrillation - Pharmacological Rate Control vs. Pace and Ablate With Conduction System Pacing","RAFT-P&A RCT","Inclusion Criteria:\n\n1. Patients with permanent AF\u002Fpersistent AF (in AF)\n2. Patients with NYHA Class II -IVa HF symptoms\n3. Guideline driven medical therapy (GDMT) for HF for at least 3 months:\n\n   * for those \\\u003C 75 years of age with an NT-proBNP of ≥ 600 ng\u002FL\n   * for those ≥ 75 years of age with an NT-proBNP ≥ 900 ng\u002FL, or ≥ 600 ng\u002FL if the patient has had a HF hospitalization within 1 year\n\nExclusion Criteria:\n\n1. In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days\n2. Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year\n3. Acute coronary syndrome \\\u003C4 weeks or coronary revascularization \\\u003C3months\n4. Unable or unwilling to provide informed consent\n5. Uncorrected primary valvular disease or prosthetic tricuspid valve\n6. Restrictive, hypertrophic, or irreversible form of cardiomyopathy\n7. Severe pulmonary diseases requiring oxygenation\n8. Patients with a known history of WHO Class I pulmonary hypertension (PH) which includes PH associated with CVD, collagen vascular disease, congenital shunts, cirrhosis and portal hypertension, HIV, hemoglobinopathies, schistosomiasis or drug-associated PH as well as those with high suspicion of irreversible pulmonary hypertension\n9. Patients enrolled in competitive clinical trials that will affect the objectives of this study\n10. Existing CRT\u002FBiVP\n11. Patients who are pregnant\n12. Guideline indication for CRT\n13. More than 20% pacing with an existing pacemaker\n14. Severe mobility limitations (ex. wheelchair bound and severe neurological conditions that limit mobility)",{"count":260,"type":22},600,[25],"Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some patients find it difficult to tolerate medications and suffer side effects from these treatments. In these instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker.\n\nA complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). There is not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of CSP with AV node ablation to optimal medical therapy for treating AF.",[264,28,265,266],"Atrial Fibrillation","Pacemaker","Arrhythmia Atrial",{"date":143,"type":38},{"date":269,"type":38},"2024-04-25",{"date":271,"type":22},"2029-12-31",{"name":273,"class":45},"Habib Khan",12,{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":283,"targetDuration":285,"studyType":134,"phases":4,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":46},"100427656","the-patients-presenting-with-congenital-heart-disease-register-artoria-r-100427656","NCT04848844","The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)","The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R): A Global Register to Investigate Factors Associated With Morbidity and Mortality in Adult Patients With Congenital Heart Disease (ACHD) on the Waiting List for Heart or Heart\u002FLung Transplantation","ARTORIA-R","Inclusion Criteria:\n\n1. The patient has to be listed as an adult transplant candidate in the country the data is obtained with an age ≥18 years\n2. The patient has to have a congenital heart defect or an inherited cardiomyopathy (specific; hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy or non-compaction cardiomyopathy) which is often included into the category ACHD\n3. Data is obtained from the first evaluation for listing or listing for heart-only or heart-combined organ transplantation\n4. Transfer of anonymised data\n5. The institution\u002Forganization agrees to the memorandum how data is managed, and scientific cooperation is planned between all institutions\n\nExclusion Criteria:\n\na. The patient is listed for a second heart transplantation (retransplantation)",{"count":284,"type":22},2000,"30 Years","Advances in surgical and medical care have led to improved outcomes in patients with congenital heart disease (CHD). As a consequence, the majority of patients nowadays survives to adulthood (adults with CHD, that is, adult CHD \\[ACHD\\]) with good quality of life. Despite the surgical success, the morbidity and mortality of ACHD is higher than in the general population and is linked to the development of heart failure (HF) in adulthood.\n\nHF occurs in approximately 25% of patients with ACHD, even in those patients in whom the congenital mal-formation has been corrected successfully in childhood. The time course and presentation are heterogeneous owing to variable congenital malformation and limitation of treatment options. ACHD with an anatomic right ventricle as the systemic ventricle (e.g., atrial switch operation in patients with transposition of the great arteries \\[TGAs\\]) and those with a functional single ventricle (e.g., Fontan circulation) appear to be at higher risk of developing HF. Young age at initial corrective surgery-often in the first 2 years of life-and lack of specific medical therapies can contribute to a high and early demand for heart transplantation in patients with ACHD.",[288,28,289,290,291],"Congenital Heart Disease","Transplant; Complication, Failure","Arrythmia","Ventricular Dysfunction","2026-06-28",{"date":143,"type":38},{"date":295,"type":38},"2020-09-02",{"date":297,"type":22},"2030-07-30",{"name":299,"class":45},"Universitätsklinikum Hamburg-Eppendorf",{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":308,"targetDuration":310,"studyType":134,"phases":4,"briefSummary":311,"conditions":312,"keywords":317,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":4},"100644842","prospective-cohort-of-acute-cardiology-referrals-in-an-ambulatory-day-hospital-setting-100644842","NCT07675434","Prospective Cohort of Acute Cardiology Referrals in an Ambulatory Day-Hospital Setting","CESAR Study: Prospective Cohort of Consecutive Patients Undergoing Cardiologic Evaluation in a Specialized Ambulatory Referral Unit","CESAR","Inclusion Criteria:\n\n\\- The study will include all consecutive patients referred to ambulatory day-hospital unit for suspicion of acute or sub-acute cardiovascular disease at the Cardiology Department of Lariboisière University Hospital.\n\nExclusion Criteria:\n\n* Patient unable to provide informed consent\n* Patient not affiliated to French social security",{"count":309,"type":22},25000,"10 Years","Suspected acute or subacute cardiovascular diseases-including chest pain, dyspnea, and palpitations-are among the most common reasons for unscheduled emergency department visits and pre-hospital referrals. Despite this high clinical burden, the diagnostic yield is often limited, with a frequent mismatch between initial clinical suspicion and final diagnosis, contributing to substantial healthcare utilization and hospitalization rates. Current evidence is largely focused on specific conditions such as acute coronary syndromes, heart failure, arrhythmias, or pulmonary embolism, and rarely integrates the full spectrum of clinical, biological, and imaging data obtained during initial evaluation.\n\nTo address this gap, we will establish a prospective cohort of all consecutive patients referred to the ambulatory day-hospital cardiology unit at Lariboisière University Hospital. This unit acts as a specialized downstream referral structure within the emergency care pathway, receiving patients after triage by emergency physicians, pre-hospital regulation services (SAMU), mobile intensive care units (SMUR), or emergency departments. Although it does not capture all suspected cardiovascular emergencies, it represents a selected real-world population deemed to require specialized acute cardiology assessment.\n\nThe primary objective is to assess the frequency of cardiac conditions diagnosed in this cohort. Secondary objectives include characterization of patient profiles and diagnostic pathways; evaluation of the diagnostic and prognostic performance of clinical, biological, imaging, and multimodal parameters using final Heart Team diagnosis as reference; analysis of prior health history and healthcare utilization; and assessment of the medico-economic burden of suspected acute cardiovascular disease. The study will further support the development of a dedicated biobank and the validation of next-generation biomarkers, including AI-driven and voice-based markers, as well as decision-support algorithms for binary classification of cardiac involvement. Through integration of multimodal data and linkage with national health records, this approach aims to improve diagnostic accuracy, risk stratification, and understanding of the healthcare impact of acute cardiovascular presentations in a real-world setting.",[313,28,314,315,316],"Acute Coronary Syndromes","Pulmonary Embolism, Deep Vein Thrombosis","HTN-Hypertension","Arrhythmia",[318,319,320,321,322],"Cardiovascular emergencies","Multimodality Imaging","Acute care","Prospective cohort","Biomarkers","2026-06-26",{"date":195,"type":38},{"date":326,"type":22},"2026-08-01",{"date":328,"type":22},"2041-08-01",{"name":330,"class":45},"Assistance Publique - Hôpitaux de Paris",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":209,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":4},"100625861","heart-failure-efficacy-and-research-trial-heart-platform-100625861","NCT07428135","Heart Failure Efficacy and Research Trial (HEART) Platform","HEART","Inclusion Criteria (HEART Platform)\n\n* Participants are eligible for inclusion if they meet all of the following:\n* Age ≥18 years (or legal age of majority in participant's country of residence).\n* Diagnosis of heart failure, and eligible to be classified into one of the HEART platform states at the time of randomization:\n* State 1: Worsening Heart Failure (WHF): currently hospitalized for acute decompensated heart failure or emergency department patients requiring intravenous therapy for heart failure; OR\n* State 2: Ambulatory Heart Failure: stable outpatients with established heart failure diagnosis, receiving ongoing HF management and without HF hospitalization within the prior 30 days.\n* Able and willing to provide written informed consent (or consent via a legally authorized representative, where applicable).\n* Meets all applicable domain-specific eligibility criteria for at least one active HEART Platform domain at the time of screening\u002Frandomization.\n\nExclusion Criteria (HEART Platform)\n\n* Participants will be excluded if any of the following apply:\n* Inability to provide informed consent (and no legally authorized representative available when applicable).\n* Not eligible for assignment to either HEART platform state (State 1 or State 2).\n* Presence of conditions or circumstances that, in the investigator's opinion, would make study participation unsafe or not feasible (e.g., inability to comply with study procedures or follow-up).\n* Does not meet the eligibility requirements for any active HEART Platform domain.\n* Any domain-specific exclusion criteria applicable to the intervention\u002Fdomain(s) for which the participant would otherwise be eligible.\n* Additional inclusion and exclusion criteria apply for each individual HEART Platform domain and will be specified in the relevant domain protocol(s).",{"count":339,"type":22},1000,[25],"The Heart Failure Efficacy and Research Trial (HEART) Platform is a multicenter, randomized platform study designed to improve outcomes for patients with heart failure through the simultaneous and sequential evaluation of multiple interventions across the spectrum of heart failure.",[28],{"date":195,"type":38},{"date":345,"type":22},"2026-07",{"date":347,"type":22},"2037-03",{"name":349,"class":45},"University of Alberta",{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":23,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":371},"100612382","transcultural-digital-solutions-in-phase-iii-cardiac-rehabilitation-100612382","NCT07252856","Transcultural Digital Solutions in Phase III Cardiac Rehabilitation","CrOss-cultural Model for Postdischarge Assistance and Sustainable Digital Solutions in Phase III Cardiac Rehabilitation: a Randomized Controlled Trial","COMPASS","Inclusion Criteria:\n\n* Age ≥ 18, men and women;\n* patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure);\n* patients who completed phase II CR and are therefore eligible for CR phase III (maintenance).\n\nExclusion Criteria:\n\n* Unable to sign the informed consent;\n* unable or unwilling to use digital devices due to mental\u002Fcognitive issues or without a support person helping them to access the respective technical devices;\n* pregnant, lactating or women planning pregnancy during the course of the trial.",{"count":359,"type":22},306,[25],"Multicenter Prospective Controlled Randomized Trial, open-label, in patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure) and an approved indication for cardiac rehabilitation (CR). Patients completing phase II CR will be randomized 1:1 to usual Phase-III care (standard care) versus standard care plus the Digitally-Enhanced Extended PrEvention \\& Rehabilitation (DEEPER) package (intervention). Primary outcome is 6-month change in composite Life's Crucial 9 (LC9) (LE8 + PHQ-9).",[28,363],"Myocardial Infarction",{"date":195,"type":38},{"date":366,"type":38},"2026-04-20",{"date":368,"type":22},"2027-07-31",{"name":370,"class":45},"Fondazione Don Carlo Gnocchi Onlus",6,{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":380,"conditions":381,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":384,"leadSponsor":386,"locationsCount":4},"100593755","a-multi-site-prospective-non-interventional-observational-data-collection-study-in-patients-undergoing-a-right-heart-catheterization-100593755","NCT07010562","A Multi-site, Prospective, Non-interventional, Observational Data Collection Study in Patients Undergoing a Right Heart Catheterization","Inclusion Criteria:\n\n* Subject is at least 18 years of age at the time of screening.\n* Subject is willing and physically able to comply with the specified evaluations as per the protocol.\n* Subject is referred for invasive hemodynamic assessment with right heart catheterization.\n* Subject has provided written informed consent using the approved consent form.\n\nExclusion Criteria:\n\n* Discretionary exclusion when the inclusion of a potential subject is not in their best interest or not in the interest of compliant performance of the study.",{"count":379,"type":22},392,"Acorai is developing a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters in patients with suspected or confirmed heart failure, and\u002For pulmonary hypertension, who require hemodynamic assessment. The device will be intended as a companion test or clinical decision support tool to be used and interpreted by qualified healthcare professionals to aid standard-of-care clinical assessment in identifying hemodynamic congestion and supporting personalized treatment of heart failure and pulmonary congestion.\n\nThis study is part of the development of a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters. It will be conducted to collect the data needed to train the machine learning models retrospectively.",[28],{"date":195,"type":38},{"date":143,"type":22},{"date":385,"type":22},"2027-02-28",{"name":387,"class":77},"Acorai AB",{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":396,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":23,"phases":399,"briefSummary":400,"conditions":401,"keywords":403,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":414},"100533152","the-heartfelt-study-100533152","NCT06222099","The HEARTFELT Study","A Pragmatic, Single-blind, Randomized Crossover Trial Testing the Effectiveness of Autonomous Remote Patient Peripheral Edema Monitoring and Reporting in HEART FailurE Compared to conventionaL remoTe Patient Monitoring.","HEARTFELT","INCLUSION CRITERIA:\n\n1. Provision of signed and dated informed consent form (wet or digital signature)\n2. Male or female, aged 22 to \\[No maximum age\\]\n3. Diagnosed with Chronic Heart failure at least 2 months prior to randomization\n4. Documented history of peripheral edema (edema in feet and lower legs), defined as at least one clinical mention in the medical record indicative of oedema during prior clinical assessment.\n5. Evidence of heart failure decompensation or elevated risk of future hospitalization, defined by one or more of the following:\n\n   a.Hospitalization for heart failure occurring at least once in the past 6 months or at least twice in the past 12 months; OR b.Receipt of intravenous\u002Fsubcutaneous diuretic therapy for heart failure (inpatient or outpatient setting) occurring at least once in the past 6 months or at least twice in the past 12 months; OR c.Emergency department or urgent care visit for heart failure decompensation, occurring at least once in the past 6 months or at least twice in the past 12 months; OR d.Clinician assessment that the participant is at high risk of heart failure hospitalization within the next 6-12 months, based on documented recent clinical course (e.g. worsening congestion, escalating diuretic requirements, recurrent decompensation, and\u002For comorbidity burden).\n6. Patients who are treated with daily diuretics.\n7. Evidence of non-adherence defined by one or more of the following:\n\n   1. Participants with ≥180 days of historical monitoring\u002Fdevice data available\n\n      ● Failure to collect ≥50% of expected days of prescribed home physiological monitoring data (e.g. weight, blood pressure, or other clinician-recommended measurements), assessed over a continuous 180-day period; OR\n\n      ● Discontinuation from a remote patient monitoring\u002Fhome monitoring program due to non-adherence; OR\n\n      ● Failure to adhere to a prescribed home-based therapy\u002Fmonitoring intervention, supported by device usage data showing \\\u003C50% of expected days of use over a continuous 180-day period.\n   2. Participants without ≥180 days of historical monitoring\u002Fdevice data available: Evidence of non-adherence may be demonstrated by low data capture over shorter windows, defined as any of the following :\n\n      ● ≤2 days of monitoring data recorded for each of the most recent 4 consecutive weeks during which any remote monitoring device was continuously available in the patient's home; OR\n\n      ● ≤3 days of monitoring data recorded in any consecutive 8 week period period during which any remote monitoring device was continuously available in the patient home; AND\u002FOR\n      * by documented non-adherence in the medical record within the last 3 years:\n\n        * Historical documentation of persistent medication and\u002For dietary non-adherence, defined as either a clear statement of ongoing non-adherence or ≥2 documented instances of non-adherence concerns (including dosing and\u002For timing, where available); OR\n        * Historical documentation on repeated clinical assessments indicating persistent difficulty adhering to recommended self-management activities (e.g. repeated failure to follow monitoring instructions, incomplete engagement with care plan, or repeated non-attendance at scheduled reviews).\n   3. For participants not previously enrolled in RPM or without sufficient historical monitoring data, non-adherence will be assessed prospectively using connected scales provided at study initiation. Objective adherence metrics derived from scale usage during the initial monitoring period will be used both to characterise baseline adherence and to support predefined subgroup analyses.\n   4. Clinical teams\u002FPIs discretion as patients being non-adherent.\n8. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of the study.\n9. Patients who are covered by an insurance plan that covers IDE-B costs (e.g. Medicare Part-B), OR written contract signed by the patient, or their provider or payor, stating that they will be liable for any trial-associated costs that Medicare would ordinarily cover if the patient were covered by Medicare.\n\n1\\. Participant has bandages to lower limbs every day 2. Participant has an amputation of both feet 3. Participant is a regular wheelchair user inside their home 4. Participant is bed-bound 5. Participant is of no fixed abode 6. Participant is taking part in a conflicting evaluation\u002Fstudy that could confound the results of this evaluation and\u002For impact clinical interventions and participant outcomes 7. Participant is unable to take diuretics 8. Participant is on a regular schedule of dialysis 9. Participant has a history of recurrent leg or feet deep vein thrombosis (DVT) (two or more episodes within the last 12 months).\n\n10\\. Participant has a history of recurrent leg or feet cellulitis episodes (two or more episodes within the last 12 months).\n\n11\\. Participant is prescribed diltiazem or verapamil on an ongoing basis. 12. Participant is pregnant or is not taking medically approved birth control if of child-bearing potential.","22 Years",{"count":398,"type":22},1500,[25],"This pragmatic randomized crossover trial looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the development of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to better data availability, which in turn will improve patient care and reduce hospitalizations for the management of worsening HF (HF hospitalizations, HFHs) in nonadherent participants with chronic HF. The study objectives are:\n\n* Primary objective: Establish if the Heartfelt device is safe to use and effective at reducing HFHs.\n* Secondary objectives:\n\n  1. Establish the effect of the Heartfelt device on data availability compared to existing remote monitoring devices.\n  2. Establish the effect of the Heartfelt device on HF clinical outcomes.\n\nParticipants will need to:\n\n* Install the device in their home for at least a year and up to 4 additional years after.\n* Reply to remote patient monitoring phone calls to follow the care plans.",[28,402],"Chronic Heart Failure",[404,405,138,406],"remote patient monitoring","chronic heart failure","non-adherent heart failure",{"date":218,"type":38},{"date":409,"type":38},"2025-10-23",{"date":411,"type":22},"2030-12-31",{"name":413,"class":77},"Heartfelt Technologies",3,{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":18,"minAge":423,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":427,"conditions":428,"keywords":430,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":442},"100490954","phase-4-enavogliflozin-outcome-trial-in-patients-with-severe-aortic-stenosis-after-transcatheter-aortic-valve-replacement-100490954","NCT05672836","ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement","A Randomized, Double-Blind, Placebo-controlled Trial to Evaluate Efficacy and Safety of a Novel Sodium-Glucose Cotransporter 2 Inhibitor, Enavogliflozin Compared to Placebo on Reducing Major Cardiovascular Events or Worsening Heart Failure in Patients With Severe Aortic Stenosis Who Underwent Transcatheter Aortic Valve Replacement (TAVR) and With Heart Failure With Preserved Ejection Fraction (HFpEF)","ENAVO-TAVR","Inclusion Criteria:\n\n1\\. Patients aged ≥19 with symptomatic aortic stenosis who underwent successful transcatheter aortic valve replacement (TAVR)\\* (either native valve or valve in valve with any approved\u002Fmarketed device).\n\n\\* A successful TAVI is defined as device success according to the VARC-2(Valve Academic Research Consortium 2) and VARC-3 criteria:\n\n1. correct positioning of a single prosthetic heart valve into the proper anatomical location AND\n2. intended performance of the prosthetic heart valve (mean aortic valve gradient \\\u003C20 mmHg, peak velocity \\\u003C3 m\u002Fs, no moderate or severe prosthetic valve regurgitation) AND\n3. absence of periprocedural complications (any type of stroke, life-threatening bleeding, acute coronary artery obstruction requiring intervention, major vascular complication requiring intervention, unresolved acute valve thrombosis, or any requirement of a repeat procedure).\n\n2\\. Heart Failure with Mildly Reduced or Preserved Ejection Fraction\n\n1. Left ventricular ejection fraction (LVEF) ≥40%\n2. structural heart disease\\_Left ventricular hypertrophy (LVH) or Left atrial enlargement\n\n   A. Left ventricular hypertrophy (LVH) with septal thickness or posterior wall thickness ≥ 1.1 cm or\n\n   B. Left atrial (LA) enlargement with at least one of the following: LA width (diameter) ≥3.8 cm or LA length ≥ 5.0 cm, or LA area ≥ 20cm2, or LA volume ≥ 55mL or LA volume index ≥ 29mL\u002Fm.\n3. NT-proBNP ≥ 300 pg\u002FmL (for patients without ongoing atrial fibrillation) or NT-proBNP must be ≥ 600 pg\u002FmL (for patients with ongoing atrial fibrillation).\n\n3\\. Patients who voluntarily participated in the written agreement\n\nExclusion Criteria:\n\n1. Acute decompensated Heart Failure (exacerbation of chronic Heart Failure) requiring intravenous diuretics, vasodilators, inotropic agents, or mechanical support, or hemodynamic instability following the transcatheter aortic valve replacement procedure.\n2. Currently receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomization; discontinuation of current use of SGLT2 inhibitor for the purposes of study enrolment is not permitted.\n3. Known allergy, hypersensitivity, or previous intolerance to an SGLT2 inhibitors.\n4. HF with reduced ejection fraction (LVEF \\\u003C40%).\n5. Type 1 diabetes mellitus or diabetes ketoacidosis.\n6. Chronic cystitis and\u002For recurrent urinary tract infection (≥2 times within 1 year).\n7. Stroke or transient ischemic attack within 12 weeks prior to enrollment.\n8. Symptomatic persistent hypotension and\u002For a systolic blood pressure (SBP) \\\u003C 95 mm Hg at screening or at randomization.\n9. SBP ≥180 mmHg irrespective of treatment or SBP ≥160 mmHg with at least ≥3 antihypertensive drugs at screening or randomization.\n10. Heart failure due to any of the following causes; known infiltrative cardiomyopathy (e.g. amyloid, sarcoid, lymphoma, endomyocardial fibrosis, haemochromatosis, Fabry disease), active myocarditis, constrictive pericarditis, cardiac tamponade, known hypertrophic obstructive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy\u002Fdysplasia (ARVD), or uncorrected primary valvular disease.\n11. Severe renal insufficiency (eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m2 of body-surface area based on the Modification of Diet in Renal Disease (MDRD) formula) or end-stage renal disease or requiring dialysis at the time of screening.\n12. Acute or chronic liver disease with severe impairment of liver function (e.g., ascites, esophageal varices, coagulopathy) or serum levels of transminases or alkaline phosphatase more than two times the upper limit of normal at screening.\n13. Chronic pulmonary disease requiring home oxygen, oral steroid therapy or hospitalization for exacerbation within 12 months, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension.\n14. Current or suspicious malignancy or history of malignancy within 5 years\n15. Uncontrolled anaemia or haemoglobin \\\u003C9g\u002Fdl\n16. Uncontrolled hypothyroidism or arrhythmia or tachycardia\n17. Current ongoing alcoholic or drug addict\n18. Subjects with non-cardiac co-morbidities with life expectancy less than 12 months\n19. Planned major high-risk operation after transcatheter aortic valve replacement (TAVR)\n20. Women of childbearing age who have not reached a consensus on the use of highly effective contraception. Pregnancy or breastfeeding.\n21. Participation in other clinical trials, However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;\n\n    * Participating in the observational study expected no effect on the safety and\u002For effectiveness evaluation of this trial.\n    * Screening failed before any interventional factor is involved.\n    * Participants who have completed their involvement in clinical trials and have surpassed a 4-week period since their last administration of the investigational drug.\n    * Participated in academic trials like strategic or medical device comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.","19 Years",{"count":425,"type":22},1040,[188],"The goal of this trial is to to determine whether use of a novel SGLT2 inhibitor, Enavogliflozin 0.3 mg once daily is superior to placebo, when added to standard-of-care, in reducing the composite of major cardiovascular events and Heart Failure events (hospitalization for Heart Failure or urgent Heart Failure visit) among patients who underwent transcatheter aortic valve replacement for severe aortic stenosis and with heart failure with preserved ejection fraction.",[429,28],"Aortic Valve Stenosis",[431,432,433,434],"Transcatheter Aortic Valve Implantation","heart failure with preserved ejection fraction","Sodium-glucose cotransporter-2 inhibitor","transcatheter aortic valve replacement",{"date":218,"type":38},{"date":437,"type":38},"2024-12-18",{"date":439,"type":22},"2029-04",{"name":441,"class":45},"Duk-Woo Park, MD",31,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":209,"sex":18,"minAge":19,"maxAge":450,"enrollmentInfo":451,"targetDuration":4,"studyType":23,"phases":453,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":46},"100641149","phase-1-a-study-understanding-how-much-cdr132l-enters-the-bloodstream-after-injection-under-the-skin-compared-to-injection-into-a-vein-in-healthy-participants-100641149","NCT07656454","A Study Understanding How Much CDR132L Enters the Bloodstream After Injection Under the Skin Compared to Injection Into a Vein in Healthy Participants","A Bioavailability Study Comparing the Pharmacokinetics of CDR132L Following Subcutaneous and Intravenous Administration in Healthy Participants","Inclusion Criteria:\n\n* Male or female (sex at birth).\n* Age 18-55 years (both inclusive) at the time of signing the informed consent.\n* Body mass index 18.5-29.9 kilograms per square metre (kg\u002Fm\\^2) (both inclusive) and body weight less than or equal to (≤) 120 kilograms (kg) at screening (visit 1).\n* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit (visit 1), as judged by the investigator.\n\nExclusion Criteria:\n\n* Any laboratory safety parameters at screening (visit 1) outside the below laboratory ranges, see laboratory manual for specific values.\n\n  * Alanine aminotransferase (ALT) greater than (\\>) upper limit of normal (ULN) +10 percentage (%)\n  * Aspartate aminotransferase (AST) \\>ULN +20%\n  * Bilirubin \\>ULN +20%\n  * Creatinine \\>ULN +10%\n  * Estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\]) less than (\\\u003C) 90 milliliters per minute\u002F1.73square meter (mL\u002Fmin\u002F1.73m\\^2)\n  * Urine albumin-to-creatinine ratio (UACR) greater than or equal to (≥) 30 milligrams per gram (mg\u002Fg)\n* Second or third degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms), or of the QT interval corrected using Fridericia's formula (QTcF) interval over 450 ms, or any other clinically significant abnormal electrocardiogram results as judged by the investigator at screening (visit 1).\n* Supine blood pressure at screening (visit 1) outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic.\n* Heart rate outside the range of 50-89 beats\u002Fminute at screening (visit 1).\n* Presence or history (as declared by the participant or reported in the medical records) of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemia, stroke, heart failure, cardiac decompensation, clinically significant arrhythmia and clinically significant conduction disorders.\n* Known history of severe symptomatic untreated anaemia in the 90 days prior to screening (visit 1) (e.g., haemoglobin \\\u003C90 grams per litre (g\u002FL))\n* Presence or history (as declared by the participant or reported in the medical records) of acute or chronic kidney disease or injury.\n* Presence of thrombocytopenia, defined as thrombocyte count \\\u003C150 x 10\\^9 cells\u002FL at screening (visit 1), or history (as declared by the participant or reported in the medical records) of bleeding disorder.\n* Presence or history (as declared by the participant or reported in the medical records) of conditions associated with disruption of blood-brain barrier (e.g. multiple sclerosis).","55 Years",{"count":452,"type":22},32,[164],"This study is being done to understand how much of the medicine (CDR132L) enters the bloodstream after injection under the skin compared to injection into a vein in healthy people. This will help us find the best way to give the medicine to people living with heart failure. The study will assess what the body does to the medicine, and how safe it is.",[456,28],"Healthy Volunteers","2026-06-25",{"date":195,"type":38},{"date":460,"type":38},"2026-06-17",{"date":462,"type":22},"2026-12-31",{"name":464,"class":77},"Novo Nordisk A\u002FS",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":209,"sex":18,"minAge":19,"maxAge":450,"enrollmentInfo":472,"targetDuration":4,"studyType":23,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":481,"locationsCount":46},"100640446","phase-1-a-clinical-study-of-hrs-7156-in-healthy-participants-100640446","NCT07601087","A Clinical Study of HRS-7156 in Healthy Participants","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Oral Doses of HRS-7156 in Healthy Participants","Inclusion Criteria:\n\n1. Healthy men and women aged 18 to 55 years old at informed consent signing;\n2. Male body weight ≥50 kg, female ≥45 kg; BMI 18.5 to 30 kg\u002Fm² at screening and baseline;\n3. Have no clinically significant abnormalities at screening and baseline;\n4. Fertile females and males with fertile female partners: effective contraception 2 weeks before consent, and sustained until 1 week after the last dose (abstinence or highly effective contraception); no sperm\u002Fegg donation.\n\nExclusion Criteria:\n\n1. A history or current severe diseases of multiple systems, or other diseases interfering with trial results;\n2. Severe infection, trauma, major surgery within 3 months before screening; planned surgery during the trial;\n3. Blood donation\u002Fsevere blood loss (≥400 mL) within 8 weeks, blood transfusion within 4 weeks before screening; planned blood donation during the trial;\n4. History of drug abuse\u002Fdependence; positive urine drug test at screening.Participation in other clinical trials within 3 months before screening or planned;\n5. participation during the trial; within 5 half-lives of a prior drug (whichever is longer);\n6. Smoking history (≥5 cigarettes\u002Fday) within 4 weeks before screening; inability to abstain from tobacco during the trial; positive smoke screening at screening\u002Fbaseline;\n7. Positive for HBsAg, HIV antibody, Treponema pallidum antibody or HCV antibody at screening;\n8. Special dietary requirements and inability to comply with the unified diet;\n9. Difficulty in swallowing\u002Fvenous blood collection; intolerance to intensive blood sampling;\n10. Other circumstances deemed unsuitable for trial participation by Researcher.",{"count":473,"type":22},66,[164],"The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants.",[28],{"date":218,"type":38},{"date":479,"type":22},"2026-06-12",{"date":345,"type":22},{"name":482,"class":77},"Shandong Suncadia Medicine Co., Ltd.",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":492,"briefSummary":493,"conditions":494,"keywords":495,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":504},"100639895","remote-monitoring-and-optimization-of-heart-failure-therapy-100639895","NCT07622472","Remote Monitoring and Optimization of Heart Failure Therapy","REMODEL-HF","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability and willingness to provide written informed consent and comply with study procedures\n* Hospital admission for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and\u002For symptoms of heart failure such as edema and\u002For positive rales on auscultation.\n* All measures within 24 hours prior to randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.\n* All measures within 24 hours prior to randomization of serum potassium ≤ 5.5 mEq\u002FL (mmol\u002FL).\n* Biomarker criteria for persistent congestion:\n\n  * NT-proBNP \\>1500 pg\u002FmL at the time of admission, and;\n  * NT-proBNP \\>1000 pg\u002FmL \\>=3 days after initial admission measure\n* At 1 week prior to admission, either (a) ≤ ½ the optimal dose of ACEi\u002FARB\u002FARNi (see Table) prescribed, no beta-blocker prescribed, and ≤ ½ the optimal dose of MRA prescribed or (b) no ACEi\u002FARB\u002FARNi prescribed, ≤ ½ the optimal dose of beta-blocker prescribed, and ≤ ½ the optimal dose of MRA prescribed. All study participants prescribed per label and commercially fit with the HFMS device will be eligible for enrollment.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Clearly documented intolerance to high doses (≥50% of target dose) of beta-blockers.\n* Clearly documented intolerance to high doses (≥50% of target dose) of RAS blockers (both ACEi and ARB).\n* Mechanical ventilation (not including CPAP\u002FBIPAP) in the 24 hours prior to Screening.\n* Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1\\\u003C 1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as precapillary pulmonary hypertension or chronic thromboembolic pulmonary hypertension.\n* Cardiac surgery within 3 months prior to Screening\n* Index Event (admission for AHF) triggered primarily by a correctable etiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation\u002Fflutter with sustained ventricular response \\>130 beats per minute, or bradycardia with sustained ventricular arrhythmia \\\u003C45 beats per minute), severe anemia, acute coronary syndrome, pulmonary embolism, planned admission for device implantation or severe nonadherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not excluded.\n* Uncorrected thyroid disease, active myocarditis, or known amyloid, sarcoidosis, or hypertrophic obstructive cardiomyopathy.\n* History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.\n* Adhesive allergy\u002Fsensitivity (e.g., acrylic adhesives).\n* Compromised skin at the device application site (wound, severe dermatitis, etc.) .\n* Having a prescribed wearable cardioverter defibrillator\n* Pulmonary artery pressure implant (e.g. CardioMems)\n* Expected survival \\\u003C1 year",{"count":491,"type":22},800,[25],"Heart failure is a condition in which the heart cannot pump blood effectively, often leading to symptoms such as shortness of breath and fluid retention. After hospitalization for heart failure, patients remain at high risk of worsening symptoms, emergency visits, and hospital readmission.\n\nThis study is designed to evaluate whether using a wearable monitoring device, called the Heart Failure Management System (HFMS), can help improve the management of patients after a recent hospitalization for heart failure.\n\nParticipants in this study will be randomly assigned to one of two groups. One group will receive standard medical care alone. The other group will receive standard medical care in combination with the HFMS device. The HFMS device is worn on the body and continuously collects information such as heart rate, breathing, activity level, and signs of fluid accumulation. These data are reviewed by the clinical care team and may help detect early worsening of heart failure.\n\nParticipants will wear the device for 90 days (if assigned to the device group) and will be followed for up to one year. During the study, information will be collected on serious health events such as death, hospitalizations, emergency visits, and changes in heart failure status, as well as quality of life.\n\nThe goal of this study is to determine whether this monitoring approach can improve outcomes for patients with heart failure by enabling earlier and more effective clinical management.",[28],[496],"Heart Failure, Remote Monitoring, Wearable Device",{"date":323,"type":38},{"date":499,"type":22},"2026-10-01",{"date":501,"type":22},"2029-08-01",{"name":503,"class":77},"Zoll Medical Corporation",9,{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":23,"phases":515,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":521,"leadSponsor":523,"locationsCount":524},"100636539","phase-3-a-research-study-to-look-at-how-well-nnc0487-0111-works-compared-to-placebo-in-people-with-heart-failure-and-obesity-100636539","NCT07567001","A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity","Efficacy and Safety of NNC0487-0111 Compared to Placebo on Morbidity and Mortality in People With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity","HF-POLARIS","Inclusion Criteria:\n\n* Body Mass Index (BMI) greater than or equal to (\\>=) 30 kilograms per square metre (kg\u002Fm\\^2) at screening.\n* Diagnosis of HF with New York Heart Association (NYHA) class II-IV and in stable condition at screening, at the discretion of the investigator.\n\nFor participants with Type 2 Diabetes (T2D) at screening:\n\n\\- Diagnosed with T2D \\>= 30 days before screening.\n\nExclusion Criteria:\n\n* MI, stroke, unstable angina pectoris or worsening HF leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization.\n* HF due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, Chagas cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, or uncorrected primary valve disease of moderate or severe degree.\n* Severe pulmonary disease including primary pulmonary hypertension, chronic pulmonary embolism, or severe chronic obstructive pulmonary disease (COPD) defined as:\n* requiring home oxygen; or - ongoing oral corticosteroid therapy; or - hospital for COPD Exacerbation within 12 months prior to screening.\n* Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism).\n\nGlycaemia-related:\n\n* History of type 1 diabetes.\n* Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.\n* Glycated haemoglobin (HbA1c) greater than (\\>) 10 percent (%) (86 \\[millimoles per mole\\] mmol\u002Fmol) as measured by local or central laboratory at screening.",{"count":514,"type":22},5610,[91],"This study is being done to look at the safety and effect of NNC0487-0111 in people with Heart Failure with preserved Ejection Fraction (HFpEF) or Heart Failure with mildly reduced Ejection Fraction (HFmrEF) and excess body weight when compared to placebo. The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have HFpEF or HFmrEF and excess body weight. Participants will get NNC0487-0111 or placebo by injection once a week. Which treatment participants get is decided by chance. NNC0487-0111 is a new medicine that doctors cannot prescribe yet, but it has been tested in people before.",[518,28],"Obesity",{"date":195,"type":38},{"date":173,"type":38},{"date":522,"type":22},"2029-08-15",{"name":464,"class":77},838,{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":539,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":550},"100511057","proactive-hf-2-trial-heart-failure-nyha-class-ii-and-iii-100511057","NCT05934487","PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III","A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II-III Heart Failure Patients","Inclusion Criteria 1. Subject has given written informed consent 2. Male or female, at least 18 years of age 3. Diagnosis and treatment of HF (regardless of LVEF) for ≥ 3 months and NYHA Class II HF (NYHA II Cohort) or NYHA III (NYHA III Cohort) at time of Screening\n\n4\\. Subjects should be receiving appropriate medical therapy for heart failure according to current AHA\u002FACC guidelines as standard-of-care for HF therapy in the United States, or current ESC guidelines for HF treatment in Europe for at least 30 days prior to the Screening\u002FEnrollment visit. Stable is defined as no more than a 100% increase or 50% decrease in dose. These criteria may be waived if a subject is intolerant of ACE-I, ARB, ARNI), MRA, beta-blockers, or SGLT2i, subject is unable to afford these agents, subject has contraindications to these agents, or these agents are not indicated under the Guidelines. Such intolerance, lack of affordability, contraindications, or lack of indications must be documented.\n\n1. HFrEF (EF \\\u003C 50%): Subject has been on stable medications maximized to the subject's tolerance of ACE-I or ARB or ARNI, MRA, beta-blockers, and SGLT2i as determined by the study investigator for at least 30 days prior to Screening\u002FEnrollment\n2. HFpEF (EF ≥ 50%): Subject has been on stable medication maximized to the subject's tolerance of SGLT2i as determined by the study investigator for at least 30 days prior to Screening\u002FEnrollment 5. NYHA II Cohort- HF related hospitalization within 6 months (last hospitalization should be 30 days before Screening \u002FEnrollment) 5. NYHA III Cohort -HF related hospitalization within 12 month (last hospitalization should be 30 days before Screening\u002FEnrollment)\n\n   6\\. Subjects should be on diuretic therapy (≥40 mg\\] furosemide or equivalent) for ≥ 1 month at time of Screening\n\n   7\\. Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 1.3lb) against the ventral thoracic surface for up to 2 minutes per day while in a seated position, as well as dock and undock the myCordella™ Patient Reader\n\n   8\\. Subjects with sufficient eyesight, hearing, and mental capacity to respond to the myCordella™ Patient Reader's audio\u002Fvisual cues and operate the myCordella™ Patient Reader\n\n   9\\. Subject has sufficient Cellular and\u002F or Wi- Fi Internet coverage at home\n\n   10\\. Subject agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up\n\n   Exclusion Criteria:\n   1. ACC\u002FAHA Stage D refractory HF (including a known history of \\>24 hours of IV inotropic therapy to support circulation within the past 6 months (other than relation to a procedure))\n   2. Subjects with history of recurrent pulmonary embolism (≥2 episodes within 5 years prior to Screening Visit) and\u002For deep vein thrombosis in the femoral or IJ vein used for access (\\\u003C 3 month prior to Screening Visit)\n   3. Subjects with a resting systolic blood pressure \\\u003C90 mmHg and\u002F or severe pre-capillary pulmonary hypertension with a pulmonary artery systolic pressure of ≥70 mm\u002FHg with pulmonary capillary wedge pressure ≤ 15 mmHg at the Cordella PA Sensor Implant RHC (V2)\n   4. Subjects who have had a major cardiovascular (CV) event (e.g., myocardial infarction, stroke) within 3 months of the Screening Visit\n   5. Unrepaired severe valvular disease\n   6. Subjects with significant congenital heart disease that has not been repaired and would prevent implantation of the Cordella PA Sensor or mechanical\u002Ftissue right heart valve(s)\n   7. Subjects with known coagulation disorders\n   8. Subjects with a hypersensitivity or allergy to platelet aggregation inhibitors including aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unable to take dual antiplatelet or anticoagulants for one-month post implant\n   9. Known history of life-threatening allergy to contrast dye.\n   10. Subjects whereby RHC is contraindicated\n   11. Subjects with an active infection at the Cordella Sensor Implant Visit\n   12. Subjects with a GFR \\\u003C20 ml\u002Fmin or who are on chronic renal dialysis\n   13. Implanted with Cardiac Resynchronization Therapy-Pacemaker (CRT-P) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D), or having undergone mitral\u002Ftricuspid valve repair\u002Freplacement within 90 days or catheter ablation for atrial fibrillation within 30 days prior to screening visit\n   14. Received or are likely to receive an advanced therapy (e.g., durable mechanical circulatory support or lung or heart transplant) in the next 24 months\n   15. Subjects who are pregnant or breastfeeding\n   16. Subjects who are unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance\n   17. Severe illness, other than heart disease, which would limit survival to \\\u003C2 years\n   18. Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study\n   19. Subjects enrolled in another investigational trial with an active Treatment Arm\n   20. Subject who is in custody by order of an authority or a court of law",{"count":533,"type":22},1750,[25],"This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial).\n\nThe study contains of 5 arms:\n\nNYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data.\n\n* Treatment Arm (Group 1)\n* Active Control Arm (Group 2)\n* Crossover Arm (Group 3)\n\nNYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy.",[537,538,28],"Heart Failure NYHA Class II","Heart Failure NYHA Class III",[28,540,541,542],"Heart Disease","Cardiovascular Disease","Pulmonary Artery Pressure",{"date":218,"type":38},{"date":545,"type":38},"2023-11-29",{"date":547,"type":22},"2033-09",{"name":549,"class":77},"Endotronix, Inc.",48,{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":558,"targetDuration":559,"studyType":134,"phases":4,"briefSummary":560,"conditions":561,"keywords":568,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":579},"100623159","biostreamcsp-study-100623159","NCT07393009","BIO|STREAM.CSP Study","Observation of Clinical Routine Care for Patients Implanted With BIOTRONIK Devices Used for Conduction System Pacing (CSP)","Inclusion Criteria:\n\n* Guideline indication for pacemaker or cardiac resynchronization therapy with or without defibrillation function (CRT-P\u002F-D)\n* Patient is intended for a de novo implantation and LBBAP therapy with an investigational generator and an investigational lead OR has just been implanted with an investigational generator and an investigational lead positioned permanently deep within the intraventricular septum and has not yet been discharged from the hospital OR transitions from the BIO\\|MASTER.CSP study\n* Ability to understand the nature of the study\n* Ability and willingness to perform all follow-up visits\n* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept\n\nExclusion Criteria:\n\n* Planned dation from intended use\n* Planned for cardiac surgical procedures, heart transplantation or interventional measures other than the study procedure within one year after enrollment\n* Life-expectancy less than 12 months\n* Pregnant or breast feeding\n* Age less than 18 years\n* Participation in an interventional clinical investigation, except for submodules within this study.",{"count":339,"type":22},"4 Years","The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.",[562,563,564,565,566,567,28],"Cardiac Pacing","Cardiac Pacemaker","Implantable Cardioverter Defibrillator","Cardiac Resynchronization Therapy Devices","Bradycardia","Tachycardia",[569,570],"Conduction system pacing (CSP)","Left bundle branch area pacing (LBBAP)","2026-06-24",{"date":218,"type":38},{"date":574,"type":38},"2026-05-25",{"date":576,"type":22},"2033-02-01",{"name":578,"class":77},"Biotronik SE & Co. KG",40,{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":588,"enrollmentInfo":589,"targetDuration":4,"studyType":23,"phases":591,"briefSummary":592,"conditions":593,"keywords":596,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":46},"100619508","exploratory-study-of-the-myheartsentinel-system-a-cardiametrics-medical-device-100619508","NCT07345533","EXPLORATORY STUDY OF THE MYHEARTSENTINEL SYSTEM, A CARDIAMETRICS MEDICAL DEVICE","EXPLORATORY STUDY OF THE MYHEARTSENTINEL SYSTEM, A CARDIAMETRICS MEDICAL DEVICE - ANALYSIS OF CARDIAC ELECTROPHYSIOLOGICAL AND MECHANICAL SIGNALS DURING A DECOMPENSATION\u002FRECOMPENSATION EPISODE IN PATIENTS WITH HEART FAILURE IN THE HOSPITAL AND UPON DISCHARGE HOME","ASEMC-DR","Inclusion Criteria:\n\n* Patients aged between 18 and 90 years\n* Affiliated with the social security system.\n* Patients who have been informed of the study and have signed informed consent.\n* Patients with heart failure and one of the following two criteria:\n\n  * Hospitalized for hemodynamic assessment\n  * Hospitalized in a cardiology unit (ICU or telemetry unit) for congestive decompensation of known heart failure defined by \\[8\\] minimal dyspnea at rest or during exercise AND an elevation of BNP \\> 400 µg\u002Fml or NT-proBNP \\> 1600 µg\u002Fml\n\nExclusion Criteria:\n\n* Patient hospitalized for decompensated heart failure due to an infectious cause requiring antibiotic treatment\n* Patient requiring intravenous inotropes within the last 24 hours\n* Patient with ventricular arrhythmias or permanent AF\n* ACS with ST+ complex complicated by heart failure\n* Valvulopathy awaiting interventional management\n* Pericardial constriction\n* Pregnant or breastfeeding women\n* Women of childbearing potential without effective contraception\n* Patients under guardianship, curatorship, legal protection, or legal protection.\n* Patients already enrolled in an interventional clinical trial that may impact the electrophysiological and cardiac mechanical measurements of the medical device under study. • Inability to position the sensor on the thoracic area of interest\n* Patients with open wounds, recent scars, or skin infections at the intended SCOUT device placement site\n* Patients suffering from dermatitis, eczema, psoriasis, or other skin conditions at the placement site.\n* Physical or psychological inability of the patient or caregiver to use the digital medical telemonitoring device and\u002For its collection accessories, as determined by the physician wishing to include the patient in the medical telemonitoring project;\n* Patient refusal to transmit the data necessary to monitor the effective use of the DMN and to obtain individualized or national real-life usage results;\n* Patient refusal to receive therapeutic support.","90 Years",{"count":590,"type":22},70,[25],"Background:\n\nChronic heart failure represents a major public health challenge, affecting approximately 64 million people worldwide and generating high costs in terms of mortality, frequent hospitalizations, and medical expenses. In France, this disease is expected to cause nearly 70,000 deaths and 181,000 hospital admissions in 2022. Current management, based on periodic consultations, fails to effectively prevent acute exacerbations, highlighting the importance of technological solutions such as remote monitoring.\n\nObjective:\n\nThis study aims to demonstrate the value of regular monitoring of electrophysiological and mechanical cardiac signals and parameters in patients with chronic heart failure. Its goal is to build a database of signals from an external measuring device (MyHeartSentinel MHS) to identify parameters that evolve in relation to biological and\u002For hemodynamic changes and\u002For the patient's clinical status. The results of this study will enable the further development of an automated monitoring solution for heart failure patients to enable early detection and management of decompensation.\n\nMaterials and Methods:\n\nA total of 70 patients diagnosed with chronic heart failure will be included, including 30 patients hospitalized for heart failure decompensation and 40 patients hospitalized for hemodynamic assessment. Electrophysiological and cardiac mechanical data will be collected using a skin-based measuring device. These data will then be correlated with biological and\u002For hemodynamic changes and\u002For the patient's clinical status. They will contribute to the training of an algorithm to detect the risk of decompensation.\n\nHypothesis Tested:\n\nAbility of MHS to detect electrophysiological and cardiac mechanical data related to cardiac decompensation, such as cardiac filling pressure.",[28,594,595],"Telemonitoring","Right Heart Catheterisation",[594,138,597,598],"right heart catheterisation","acute heart failure",{"date":323,"type":38},{"date":601,"type":38},"2025-07-17",{"date":603,"type":22},"2028-03-17",{"name":605,"class":45},"University Hospital, Caen",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":614,"enrollmentInfo":615,"targetDuration":4,"studyType":23,"phases":617,"briefSummary":618,"conditions":619,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":620,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":627},"100533203","effect-of-personalized-follow-up-in-adapted-physical-activities-in-subjects-with-chronic-heart-failure-100533203","NCT06222762","Effect of Personalized Follow-up in Adapted Physical Activities in Subjects With Chronic Heart Failure.","Effect of a Personalized Follow-up in Adapted Physical Activities on the Long-term Benefits of Rehabilitation in Subjects With Chronic Heart Failure.","BougeTonCoeur","Inclusion Criteria:\n\n* Diagnosis of stable heart failure with NYHA stage I, II or III\n* Participation in a cardiac rehabilitation programme\n* Patient agreement\n* Patient of legal age\n* Patient affiliated to the Social Security\n\nExclusion Criteria:\n\n* Patient refusal\n* Minor patients\n* Subjects under guardianship or curatorship\n* Subjects over 80 years of age at the time of inclusion","80 Years",{"count":616,"type":22},90,[25],"France has one million people with heart failure (HF). Exercise intolerance, characterised by dyspnoea, is the main clinical symptom in HF patients and a key determinant of reduced quality of life. In addition to drug and surgical treatments, cardiac rehabilitation programmes have shown benefits in heart failure patients. Lasting at least 3 weeks, these programmes improve physical abilities, quality of life and reduce the risk of hospitalisation for heart failure patients.\n\nTo date, the real challenge is no longer to prove the benefits of cardiac rehabilitation, but to find solutions to maintain its long-term effects. The transition between the end of the supervised programmes in the centre and the return home is a difficult phase for the majority of patients who do not continue regular physical activity and thus quickly lose the benefits of the programme.\n\nTo help maintain the benefits of cardiac rehabilitation, some centres offer patients programmes to continue physical activity during phase III. Although these options are often beneficial in the first few months after the end of rehabilitation compared to control groups, the long-term results are mixed. These results imply that one of these maintenance options may not be suitable for all patients. It is therefore important to propose a personalised post-rehabilitation follow-up involving the patient in the choice of physical activities to optimise the maintenance of long-term benefits.\n\nWe hypothesise that patients who receive personalised support from a sport and health professional following rehabilitation maintain long-term benefits compared to a control group who do not receive this support.",[28],{"date":323,"type":38},{"date":622,"type":38},"2024-02-13",{"date":624,"type":22},"2027-09-13",{"name":626,"class":45},"University Hospital, Brest",2]