[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure-hf\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure-hf":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,40,75,104,133,164,194,223,249],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100644611","non-invasive-hemodynamic-monitoring-in-hospitalized-heart-failure-100644611",false,"NCT07671742","Non-Invasive Hemodynamic Monitoring in Hospitalized Heart Failure","Hemodynamic Observational Study in Patients With Heart Failure Using a Non-Invasive Multi-Modal Sensing Device (HOSP-HF)","Inclusion Criteria:\n\n* Age ≥18 years\n* Hospitalization for primary heart failure, defined as new or worsening heart failure symptoms with objective evidence of congestion requiring initiation or intensification of heart failure-specific therapy\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Any discretionary exclusion where the inclusion of the subject is deemed to pose potential risks to the subject's well-being or is likely to comprise the compliant performance of the study.\n* Pregnancy or lactation (as confirmed by self-report or medical documentation)\n* Presence of a skin rash or open wound in the area where the Acorai Device model 1.0 will be applied\n* Any other condition that, in the opinion of the investigator, would preclude the subject from participating in the study or may affect the integrity of the data","ALL","18 Years",{"count":19,"type":20},1000,"ESTIMATED","OBSERVATIONAL","Heart failure hospitalization is associated with a high risk of early readmission and mortality. There is an unmet clinical need for low-burden, non-invasive methods to better understand congestion and hemodynamic status during hospitalization.\n\nThis observational study evaluates the association between non-invasive measurements obtained with the Acorai Device 1.0 and clinical data collected during hospitalization and up to 90 days after discharge in patients admitted with heart failure. The device performs short, non-invasive recordings that collect physiological signals from the thoracic region without influencing clinical care.\n\nParticipants will undergo daily recordings during hospitalization. Clinical information and outcomes, including heart failure hospitalization and all-cause mortality within 90 days after discharge, will be collected from medical records. The study aims to explore relationships between non-invasive sensor measurements and clinical outcomes in hospitalized heart failure patients.",[24,25,26],"Heart Failure","Heart Failure Hospitalization","Heart Failure (HF)","RECRUITING","2026-06-23",{"date":30,"type":31},"2026-06-26","ACTUAL",{"date":33,"type":31},"2026-04-01",{"date":35,"type":20},"2027-04-01",{"name":37,"class":38},"Acorai AB","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":49,"conditions":50,"keywords":54,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":39},"100631299","detecting-the-undetected-heart-failure-screening-at-the-lymphoedema-point-of-care-100631299","NCT07498868","Detecting the Undetected: Heart Failure Screening at the Lymphoedema Point of Care","Detecting the Undetected: an Observational Cohort Study Evaluating the Health Economics, Clinical Utility, and Patient and Staff Experiences of Innovative Peptide Testing to Screen for Heart Failure in Lymphoedema Clinics","Inclusion Criteria:\n\n* Patient of Swansea Bay University Health Board Lymphoedema Service.\n* Consent to participate in the study.\n* Bilateral lower limb oedema.\n* Aged 18-years or older.\n* Able to provided informed consent to be involved.\n* No diagnosis of heart failure.\n* No NT-proBNP test in the previous 12-months OR increase in lymphoedema severity since an NT-proBNP test in the last 12-months.\n\nExclusion Criteria:\n\n* All inclusion criteria not met.\n* Not a lymphoedema patient in Swansea Bay University Health Board Lymphoedema Service.\n* Unable to consent for themselves.\n* Women who are pregnant or have given birth in the last 6-months.\n* Patients with an existing heart failure diagnosis.",{"count":48,"type":20},618,"Heart failure affects more people than the four most common cancers combined. When identified early, management is more straightforward, preventing complications, hospitalisations, and fatalities. Breathlessness and fatigue are cardinal symptoms of heart failure that can present in a number of conditions. As a result, leg swelling, the third cardinal symptom, is the first noted in many people. The presence of leg swelling leads to patients being seen in lymphoedema clinics before the need for cardiology investigation has been identified. Lymphoedema is the presence of chronic oedema as a result of congenital abnormalities, inflammation, infection, trauma, or cancer and its treatments. The vast majority of lymphoedema patients have swelling in their legs.\n\nA recent study has shown that 9.4% lymphoedema patients need to be investigated for heart failure. At present, the need for investigation is identified by performing a laboratory blood test, which takes time to arrange and complete. An alternate point of care test can provide a result in 12-minutes at the lymphoedema appointment, and enable appropriate action to be taken. This can reduce the demands on primary care and shorten the chain of events to a specialist assessment, as well as reducing inappropriate referrals.\n\nThis research, funded by NHS Wales Performance and Improvement, will perform a point of care test to screen for possible heart failure in lymphoedema clinics and establish the clinical utility by exploring the experiences of patients and staff involved and determining the health economic benefits. A supplementary aim is to compare the point of care test to the currently used laboratory test in a subsample to promote confidence in the test and support efforts to spread and scale across all health boards in Wales on completion.",[51,52,24,53,26],"Lymphedema, Lower Limb","Lymphedema","Heart Failure (for Example, Fluid Overload)",[55,56,57,58,59,60,61,62,63],"lymphoedema","heart failure","undetected heart failure","undiagnosed heart failure","bilateral lower limb oedema","bilateral leg oedema","point of care testing","screening","NT-proBNP","NOT_YET_RECRUITING","2026-03-23",{"date":67,"type":31},"2026-03-27",{"date":69,"type":20},"2026-05",{"date":71,"type":20},"2028-09",{"name":73,"class":74},"Swansea Bay University Health Board","OTHER",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":39},"100583447","effect-of-the-home-based-digital-assisted-dyadic-tai-chi-hdtc-training-program-among-sedentary-individuals-with-hf-and-their-caregivers-a-randomized-controlled-trial-100583447","NCT06876441","Effect of the Home-based Digital-assisted Dyadic Tai Chi (HDTC) Training Program Among Sedentary Individuals With HF and Their Caregivers: a Randomized Controlled Trial","A Randomized Controlled Trial to Evaluate the Effect of the Home-based Digital-assisted Dyadic Tai Chi (HDTC) Training Program Among Sedentary Individuals With Heart Failure (HF) and Their Caregivers.","Inclusion Criteria:\n\n* CHF individuals:\n\n  * aged 18 to 75 years\n  * diagnosed with CHF, regardless of the HF phenotype (HFrEF, HFmrEF, and HFpEF)\n  * categorized as NYHA class I, II or III\n  * 6MWD \\>150 meters (mild to moderate HF)\n  * stable phase of disease in the past four weeks and capable of independently practice Tai Chi without any musculoskeletal disorders that may impede joint movement\n  * sit more than 8 h\u002Fd in the past month\n  * own a smartphone\n  * volunteer to participate and provide informed consent.\n* caregivers:\n\n  * age ≥18 years old\n  * primary caregiver at home, who has emotional ties or social obligations with CHF individuals and provides daily care\n  * able to exercise Tai Chi without help\n  * volunteer to participate and provide informed consent.\n\nExclusion Criteria:\n\n* HF individuals:\n\n  * plan to undergo surgery within the next 6 months\n  * have severe comorbidities, such as cancer, liver or kidney failure, or diagnosed psychiatric disorders\n  * plan to be admitted to a nursing home or other care facilities\n  * regularly practice Tai Chi or engaging in other forms of exercise in the past 3 months (at least 3 times per week, at least 20 minutes of regular exercise each time)\n  * currently participate in similar or related studies.\n* caregivers: · formal caregivers, such as nurses, will be excluded.","75 Years",{"count":84,"type":20},256,"INTERVENTIONAL",[87],"NA","The full scale RCT aims to assess the effectiveness of the HDTC training program in improving functional capacity, cardiac function and secondary outcomes among sedentary chronic heart failure (CHF) individuals, while simultaneously reducing care burden and improving other outcomes for their caregivers.",[26],[56,91,92,93,94],"Tai Chi","dyadic","cardiac function","care burden","2026-03-08",{"date":97,"type":31},"2026-03-11",{"date":99,"type":31},"2025-04-01",{"date":101,"type":20},"2026-04",{"name":103,"class":74},"The Hong Kong Polytechnic University",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100626489","novel-technologies-to-improve-echocardiographic-estimates-of-left-ventricular-filling-pressure-in-heart-failure-combined-with-atrial-fibrillation-100626489","NCT07436299","Novel Technologies to Improve Echocardiographic Estimates of Left Ventricular Filling Pressure in Heart Failure Combined With Atrial Fibrillation","Novel Technologies to Improve Echocardiographic Estimates of Left Ventricular Filling Pressure in Heart Failure Combined With Atrial Fibrillation: A Prospective Multicenter Study","HFcAF","Inclusion Criteria:\n\n* Atrial fibrillation (paroxysmal, persistent, or permanent)\n* Scheduled for RHC or LHC for clinical reasons\n* Able to undergo echocardiography and invasive pressure measurement within 8 hours\n* No cardiovascular medication changes between echo and catheterization\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Mitral stenosis or mitral annular calcification causing severe functional stenosis\n* Severe mitral or severe tricuspid regurgitation\n* Prosthetic mitral valve\n* Atrial fibrillation with rapid ventricular response \\>120 bpm\n* Suboptimal echocardiographic imaging\n* Conditions rendering PCWP or LVEDP unreliable\n* Pregnant women\n* Complex congenital heart disease\n* LV assist device and patients with severe non-cardiac disease with poor prognosis\n* Cardiac transplant patients\n* End-stage liver disease",{"count":113,"type":20},400,"Heart failure and atrial fibrillation are two of the most common heart diseases globally. Nearly half of all patients with heart failure also have atrial fibrillation. When heart failure and atrial fibrillation occur together, the risk of hospitalization and premature death increases significantly. However, there is a lack of reliable tools to assess how severely the heart is affected in these patients. This makes it difficult both to establish the correct diagnosis, tailor treatment, and predict who is at greatest risk of hospital admission or death from the disease.\n\nOne of the most important targets in heart failure is the filling pressure in the left ventricle. When this pressure is high, it means that the heart has difficulty receiving blood, leading to shortness of breath and fluid retention in the body. Today, filling pressure is usually estimated using ultrasound (echocardiography), but the available methods are primarily developed for patients without atrial fibrillation. In patients with both heart failure and atrial fibrillation, the measurements are so uncertain that they cannot be used as a reliable basis for clinical decision-making.\n\nIn this study, entitled Heart Failure combined with Atrial Fibrillation (HFcAF), the investigators will test new ultrasound methods that combine novel measures of cardiac chamber function with established techniques. Artificial intelligence will be used to identify the most useful combinations of parameters, select cardiac cycles that are best suited for analysis in atrial fibrillation, and automate and optimize the measurements. This approach may provide both more accurate and faster assessments, while also making the methods easier to implement in clinical practice. The aim is to improve the estimation of filling pressure so that it becomes more precise also in patients with atrial fibrillation. The investigators will then examine whether these improved methods can be used to predict which patients are at highest risk of hospitalization or death due to heart failure.\n\nThe study is designed as a prospective multicenter study, in which patients are recruited from several hospitals in different countries. This will make the results robust and generalizable to a wide range of patient populations. The investigators anticipate that the project will pave the way for better diagnostics and risk stratification in heart failure combined with atrial fibrillation and, in the longer term, contribute to improved guidelines and treatment for a large number of patients. If successful, the project will provide a new tool that can contribute to earlier and more targeted treatment, thereby improving quality of life and prognosis for a large group of patients.",[26,116],"Atrial Fibrillation (AF)",[118,119,120,121,122],"Heart failure","Atrial fibrillation","Echocardiography","Filling pressure","Diastolic function","2026-03-03",{"date":125,"type":31},"2026-03-05",{"date":127,"type":20},"2026-02",{"date":129,"type":20},"2029-12",{"name":131,"class":74},"Oslo University Hospital",15,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":85,"phases":143,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":39},"100624729","evaluation-of-remote-motivational-interviewing-for-disease-management-in-heart-failure-patients-and-their-carers-100624729","NCT07413419","Evaluation of Remote Motivational Interviewing for Disease Management in Heart Failure Patients and Their Carers","REMIND HF - Evaluation of Remote Motivational Interviewing for Disease Management in Heart Failure Patients and Their Carers","REMIND-HF","Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Diagnosis of heart failure.\n* New York Heart Association (NYHA) functional class II-IV.\n* Poor self-care as assessed at baseline.\n* Receiving care at the participating heart failure clinic.\n* Access to the internet and a device capable of videoconferencing.\n* Ability to understand the study procedures and provide written informed consent.\n* Having an identified primary informal caregiver willing to participate in the study.\n* Informal caregivers aged 18 years or older.\n* Caregivers identified by the patient as the primary person providing unpaid support in daily disease management.\n* Caregivers able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Severe cognitive impairment that would limit the ability to participate in the intervention or complete study assessments.\n* Acute coronary syndrome or other acute cardiac event within the last 3 months.\n* Residence in a nursing home or long-term care facility.\n* Inability to participate in videoconferencing sessions.\n* Participation in another interventional study that could interfere with the outcomes of this trial.",{"count":142,"type":20},600,[87],"Heart failure (HF) is a chronic and progressive condition that significantly affects patients' quality of life and increases the burden on family caregivers. Many patients struggle with self-care, including medication adherence, diet, and symptom monitoring.\n\nThe REMIND HF (REmote Motivational INterviewing for Disease Management in Heart Failure) study aims to evaluate the effectiveness of remote motivational interviewing (MI) as a behavioral intervention to improve disease management and self-care among heart failure patients and their informal caregivers. The intervention consists of a series of online motivational interviews conducted by trained nurses over a 12-month period, focusing on lifestyle modification, self-monitoring, and patient-caregiver cooperation.\n\nThe study will be conducted at the Wroclaw Medical University and collaborating centers. It will enroll 300 patients with heart failure (The New York Heart Association Functional Classificaion - NYHA class: II-IV) and their primary caregivers. Outcomes will include self-care behaviors, quality of life, psychological well-being, and health service utilization. The results will contribute to developing accessible, patient-centered models of heart failure management based on telehealth and behavioral support.",[26,146,147,148],"Self Care","Caregiver","Motivational Interviewing (MI)",[56,150,151,152,153,154],"Self-Care","Motivational Interviewing","caregivers","telehealth","nursing","2026-02-11",{"date":157,"type":31},"2026-02-17",{"date":159,"type":20},"2026-02-28",{"date":161,"type":20},"2028-01-30",{"name":163,"class":74},"Wroclaw Medical University",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":171,"targetDuration":4,"studyType":85,"phases":173,"briefSummary":174,"conditions":175,"keywords":180,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":39},"100621559","left-bundle-branch-pacing-in-patients-with-hypertrophic-cardiomyopathy-after-myectomy-100621559","NCT07372196","Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy","LEFTpaceHCM","Inclusion criteria:\n\n* Men and women aged 18 years and older;\n* Patients with post-myectomy HCM who develop LBBB with a QRS complex greater than 130 ms and a high risk of SCD (HCM Risk-SCD ≥ 6%);\n* Signed informed consent to participate in the study;\n\nExclusion criteria:\n\n* Absence of QRS complex morphology consistent with LBBB in LBBB with a positive QRS complex less than 130 ms;\n* Presence of baseline complete RBBB;\n* Heart transplantation or implantation of an LVAD is planned within the next 6 months;\n* Patients with intermediate or low risk of SCD;\n* History of AMI less than three months prior to study inclusion;\n* Acute renal and hepatic failure;\n* Acute infectious diseases;\n* Presence of mental illness;\n* Presence of other illnesses for which life expectancy is less than one year;\n* Patient refusal to participate in the study at any stage;",{"count":172,"type":20},30,[87],"Pilot interventional randomized clinical trial to study the efficacy of left bundle branch pacing in patients with hypertrophic cardiomyopathy after myectomy for the prevention of progression of heart failure, prevent the occurrence of life-threatening rhythm disturbances and promote reverse remodeling of the LV.\n\nThe aim of the study is to evaluate the comparative efficacy and safety of implantation of a cardioverter-defibrillator with left bundle branch block pacing and a dual-chamber cardioverter-defibrillator in patients with HCM and complete left bundle branch block after myectomy at high risk of SCD.\n\nObjectives of the study:\n\n1. To analyze the safety of ICD implantation procedures with LBBB pacing in patients with HCM and LBBB after myectomy at high risk of SCD;\n2. To develop a technique for LBBB lead implantation in patients with HCM and LBBB after myectomy;\n3. To conduct a comparative analysis of QRS complex duration data based on ECG data before and after surgery, LV activation time, and pacing threshold based on postoperative programming data;\n4. To conduct a comparative analysis of the functional class of CHF, NT-proBNP, the presence\u002Fabsence of interventricular and intraventricular dyssynchrony, the degree of diastolic dysfunction, LVEF, and LV EDV based on echocardiography data before and 12 months after surgery;\n5. Conduct a comparative analysis of QRS complex duration data based on ECG data, LV activation time, pacing threshold, the presence of recorded episodes of AF, VT, VF, antitachycardia and shock therapy according to programming data at 3, 6, and 12 months after surgery;\n6. Assess quality of life before and 12 months after surgery using the KCCQ-12 questionnaire; 30 patients (15 patients in each group) will be randomly separated into 2 groups. All participants go through ICD programming at 3, 6, and 12 months after myectomy, assessment of left ventricular remodeling based on ECG and echocardiography, NT-proBNP, assessment of quality of life before surgery and 12 months after surgery.",[176,177,178,179,26],"HCM - Hypertrophic Cardiomyopathy","Sudden Cardiac Death","Left Bundle Branch Pacing","ICD",[181,182,178,179,118,183],"sudden cardiac death","Hypertrophic Cardiomyopathy","myectomy","2026-01-20",{"date":186,"type":31},"2026-01-28",{"date":188,"type":31},"2025-11-14",{"date":190,"type":20},"2027-07-01",{"name":192,"class":193},"Meshalkin Research Institute of Pathology of Circulation","NETWORK",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":202,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":85,"phases":206,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":39},"100597476","effects-of-enhanced-external-counterpulsation-combined-with-cardiac-rehabilitation-in-patients-with-atrial-fibrillation-100597476","NCT07058987","Effects of Enhanced External Counterpulsation Combined With Cardiac Rehabilitation in Patients With Atrial Fibrillation","A Prospective Randomized Controlled Study on the Effects of Enhanced External Counterpulsation Combined With Cardiac Rehabilitation on Cardiac Function and Exercise Capacity in Patients With Atrial Fibrillation","EECP AF CR","Inclusion Criteria:\n\n* Age between 40 and 80 years\n* Diagnosed with persistent or paroxysmal atrial fibrillation, confirmed by ECG or Holter\n* Stable medical condition and able to participate in cardiac rehabilitation and EECP therapy\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Recent acute myocardial infarction, unstable angina, or decompensated heart failure within the past 4 weeks\n* Severe valvular heart disease or left ventricular ejection fraction \\\u003C30%\n* Severe peripheral vascular disease or deep vein thrombosis\n* Severe pulmonary disease or active infection\n* History of bleeding disorders or contraindications to EECP\n* Cognitive impairment or psychiatric condition affecting study participation\n* Participation in another clinical trial within the past 3 months","40 Years","80 Years",{"count":205,"type":20},200,[87],"This is a prospective randomized controlled trial designed to evaluate the effectiveness of enhanced external counterpulsation (EECP) combined with cardiac rehabilitation in patients with atrial fibrillation. The study aims to assess whether this combined intervention can improve cardiac function and exercise capacity compared to standard care alone. Eligible participants will be randomly assigned to receive either the EECP plus cardiac rehabilitation program or routine treatment. Primary outcomes include changes in left ventricular ejection fraction (LVEF) and six-minute walking distance (6MWD). The study will be conducted at Lanzhou University Second Hospital.",[116,26,209],"Cardiac Rehabilitation",[211,209,212,213],"Atrial Fibrillation","Enhanced External Counterpulsation","Exercise Capacity","2025-07-09",{"date":216,"type":31},"2025-07-14",{"date":218,"type":20},"2025-07-15",{"date":220,"type":20},"2026-03",{"name":222,"class":74},"Lanzhou University Second Hospital",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":85,"phases":232,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":39},"100593015","diagnostic-electrical-cardioversion-for-explaining-patients-af-and-hf-symptoms-100593015","NCT07000942","Diagnostic Electrical Cardioversion for Explaining Patient's AF and HF Symptoms","DEEP-AF-HF","Inclusion Criteria:\n\n1. Male or female patients with age ≥ 18 years\n2. Diagnosis of HF ≥90 days prior to screening NYHA class ≥ 2 on guideline-directed medical therapy.\n3. ECG-confirmed AF\u002FAtrial flutter at screening\n4. Received oral anti-coagulants for ≥ 3 weeks (DOAC, vitamin K antagonists with an INR between 2 and 3) prior to screening\n5. Patients eligible for both treatment strategies judged by the investigator and physician.\n6. Provide written dated informed consent for participation prior to trial admission.\n\nExclusion Criteria:\n\nA potential patient who meets any of the following criteria will be excluded from participation in this study:\n\n1. Inability to understand and sign informed consent form\n2. Hospitalization for acute HF or worsening HF ≤ 3 months prior to screening\n3. Heart rate during AF\u002F atrial flutter ≥ 110 bpm, despite optimal rate control therapy at screening\n4. Paroxysmal or permanent AF\u002Fatrial flutter\n5. Previous left atrial ablation or surgery ≤ 3 months prior to screening\n6. Planned catheter ablation at time of screening\n7. AF due to a reversible cause (e.g. post-operative AF, hyperthyroidism)\n8. Recent acute coronary syndrome, stroke\u002Ftransient ischemic attack or cardiac intervention (≤90 days). Cardiac interventions include percutaneous coronary intervention, coronary artery bypass grafting, and heart valve repair or replacement (endovascular or surgical)\n9. Presence of (or scheduled for) mechanical assist device or heart transplantation\n10. Patients with complex congenital heart disease, up to the discretion of the investigator.\n11. Patients with current echocardiographic evidence of severe aortic-, mitral-, tricuspid- or pulmonary- valve disease (either stenosis or regurgitation)\n12. Patients with an intracardiac thrombus\n13. Expected life span from time of enrolment of ≤1 year, as assessed by the clinician\n14. Patient currently enrolled in another randomized clinical trial",{"count":231,"type":20},112,[87],"Rationale:\n\nThe co-existence of Atrial Fibrillation (AF) and Heart Failure (HF) is associated with increased morbidity, mortality, and hospital admissions, significantly contributing to healthcare burden. Patients often experience overlapping symptoms, complicating identifying the disease primarily responsible for symptom burden. Electrical cardioversion (ECV) has been suggested to assess symptom status in sinus rhythm. However, the role of a diagnostic ECV in patients with AF and concomitant HF has not been established.\n\nThe hypothesis of this trial is that a diagnostic ECV can provide insight into AF-specific and HF-specific symptoms that can inform the physician and subsequently lead to treatment changes, as well as improve quality of life (QoL), and result changes in ejection fraction, cardiac output, and NT-proBNP levels.\n\nObjective: To assess whether a diagnostic ECV results in more treatment changes after 3 months, compared to standard of care (no ECV).\n\nStudy design: This is an investigator initiated, randomized, open label with blinded endpoint evaluation, multi-centre, trial.\n\nStudy population: 112 patients with chronic HF and ECG confirmed persistent AF.\n\nTrial intervention: Patients will be randomized in a 1:1 ratio to either an ECV or standard of care with pharmacological rate and\u002For rhythm control.\n\nMain study parameters\u002Fendpoints:\n\nThe primary outcome: total number of treatment alterations by the physician during 3 months post intervention\u002Frandomization.\n\nSecondary outcomes: Success rate of ECV, recurrences of AF at 4 weeks, QoL changes assessed by AFEQT and KCCQ score, echocardiographic changes (left ventricular ejection fraction (LVEF) and cardiac output (CO)), and laboratory changes (NT-proBNP) between baseline (pre-cardioversion) and 4 weeks (post-cardioversion). Whether the physician can distinguish AF from HF symptoms and whether ECV can be used as diagnostic tool.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is a pragmatic trial, the study will be embedded within care according to current AF and HF guidelines, that includes ECV and rhythm and\u002For rate control, while acknowledging wide variability in local practises. The patients in the intervention arm will undergo a diagnostic ECV. Both groups will fill out questionnaires regarding QoL (baseline and 4 weeks) and have an echocardiogram at 4 weeks. A blinded endpoint committee will assess potential treatment alterations prescribed by the physician in both patient groups within 3 months. No harm is expected for this study as the intervention will be based on national guidelines.",[116,26,235],"Electrical Cardioversion",[237,238,239],"Electrical cardioversion","Quality of Life (QoL)","Treatment changes","2025-05-22",{"date":242,"type":31},"2025-06-03",{"date":244,"type":20},"2025-08-01",{"date":246,"type":20},"2027-12-01",{"name":248,"class":74},"M. Rienstra",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":257,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":85,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":272},"100373998","hemotag-assessment-for-short-term-outcomes-of-heart-failure-100373998","NCT04149743","HEMOTAG® Assessment for Short-term Outcomes of Heart Failure","HEMOTAG® Assessment for Short-term Outcomes of Heart Failure [HATS-OFF]","HATS-OFF","Inclusion Criteria:\n\n* Age greater than or equal to 22 years old.\n* An index hospital admission for ADHF presenting with symptoms, clinical signs, and chest x-ray (CXR) findings of pulmonary congestion, receiving IV diuretics or vasoactive drugs and having a BNP \\> 350 or NT-pro BNP \\> 1800 pg\u002Fml.\n* Able to give informed consent.\n* Participant's residence has adequate cellular data coverage.\n* Participants with previous diagnosis of left ventricular ejection fraction (LVEF) \\\u003C40% prior to the index hospitalization must have been treated for at least 90 days prior to enrollment with diuretics and beta-blocker (unless intolerant or contraindicated) and an ACE inhibitor or ARB or ARNi (unless intolerant or contraindicated).\n\nExclusion Criteria:\n\n* Participants unable to provide informed, voluntary decision to participate in research study as determined by the investigator. (Exclude participants who necessitate the involvement of a legally authorized representative.)\n* Terminal condition with life expectancy less than 6 months as determined by investigator.\n* Participants with cardiac tamponade or constrictive pericarditis.\n* Participants with left ventricular assistance device (LVAD device) or had a cardiac transplantation or listed for transplantation.\n* Implantation of a CRT (cardiac resynchronization therapy) device during index hospitalization or intent to implant a CRT device.\n* Presence of hemodynamically significant mitral and\u002For aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation, as determined by investigator.\n* Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis, as determined by investigator.\n* Severe primary pulmonary, renal or hepatic disease, as determined by investigator.\n* Women of childbearing age (Age \\\u003C50).\n* History of pulmonary embolism of less than 3 months.\n* Dialysis dependent or dialysis initiation expected within three months.\n* Chronic home IV therapy or cardiac inotropes or diuretics.\n* Physical deformity in the chest area or lesion that may prevent proper HEMOTAG application or adjustment.\n* Illness\u002F Condition which may be aggravated or cause significant discomfort by the application of the HEMOTAG (skin issues, e.g. Intolerance to use of skin electrodes).\n* Impaired cognitive ability or any other state that may prevent full compliance with the study protocol, according to investigator's assessment.\n* Congenital heart malformations (Complex, or uncorrected congenital heart disease).\n* Participant enrolled in another interventional study (observational or registries are not excluded).\n* Participant HF is managed remotely with another monitoring device or program (for example: Pulmonary\u002F Lt Atrial pressure monitoring, lung fluid monitoring. BNP\u002Fpro-BNP or bioimpedance or ICD or biventricular pacemaker with impedance monitoring will be allowed unless it is part of another research protocol).\n* Prisoners and wards of the state.\n* Inability to provide informed consent (Must speak English or Spanish or Creole).","22 Years",{"count":259,"type":20},420,[87],"Evaluation of the HEMOTAG® system in a less controlled environment and concurrently develop the system for use by patients with heart failure.",[26],"2024-08-19",{"date":265,"type":31},"2024-08-21",{"date":267,"type":31},"2022-01-31",{"date":269,"type":20},"2024-12",{"name":271,"class":38},"Aventusoft, LLC.",2]