[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure-nyha-class-iii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure-nyha-class-iii":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,46,76,102,133,161,185,210,238,263,290,316,342,365,402],{"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":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100511057","proactive-hf-2-trial-heart-failure-nyha-class-ii-and-iii-100511057",false,"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","ALL","18 Years",{"count":19,"type":20},1750,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.",[26,27,28],"Heart Failure NYHA Class II","Heart Failure NYHA Class III","Heart Failure",[28,30,31,32],"Heart Disease","Cardiovascular Disease","Pulmonary Artery Pressure","RECRUITING","2026-06-25",{"date":36,"type":37},"2026-06-29","ACTUAL",{"date":39,"type":37},"2023-11-29",{"date":41,"type":20},"2033-09",{"name":43,"class":44},"Endotronix, Inc.","INDUSTRY",48,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100426178","promoting-well-being-and-health-in-heart-failure-100426178","NCT04829617","Promoting Well-being and Health in Heart Failure","A Novel Behavioral Intervention to Promote Adherence in Heart Failure","Inclusion Criteria:\n\n* Adult patients with NYHA class I, II, or III HF.\n* Suboptimal adherence to health behaviors. This will be defined as a total score of ≤15 on three Medical Outcomes Study Specific Adherence Scale (MOS) items regarding diet\u002Fexercise\u002Fmedications.\n\nExclusion Criteria:\n\n* Cognitive deficits impeding a participant's ability to provide informed consent or participate, assessed via a 6-item cognitive test.\n* Medical conditions likely to lead to death within 6 months.\n* Inability to participate in physical activity due to another medical condition (e.g., arthritis).\n* Inability to read, write, or speak in English.\n* Current participation in another intervention or program that has been designed to promote well-being or health behavior adherence.",{"count":54,"type":20},280,[23],"The focus of this study is to test the efficacy of a 12-week, phone-delivered Positive Psychology-Motivational Interviewing (PP-MI) intervention, with additional twice weekly PP and health behavior text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks), compared to an attention-matched MI-based educational condition, in a randomized trial (NIH Stage II) of 280 patients with New York Heart Association class I-III Heart Failure (HF).",[28,58,26,27],"Heart Failure NYHA Class I",[60,61,62,63,64],"Positive Psychology","Physical Activity","Low-Sodium Diet","Medication Adherence","Motivational Interviewing","2026-04-09",{"date":67,"type":37},"2026-04-14",{"date":69,"type":37},"2021-11-29",{"date":71,"type":20},"2027-06-30",{"name":73,"class":74},"Massachusetts General Hospital","OTHER",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":75},"100611934","heart-failure-management-for-patient-with-cied-remotely-monitored-100611934","NCT07247032","Heart Failure Management for Patient With CIED Remotely Monitored","Prospective Real World Heart Failure Management for Patient With CIED Remotely Monitored","PROACT-HF","Inclusion Criteria:\n\n* Patient aged 18-85\n* Patient diagnosed with a New York Heart Association (NYHA) class II or III\n* Patients with left ventricular ejection fraction ≼ 40 %\n* Patient implanted with an ICD or CRT-D (BiV and\u002For LBBA pacing) since at least 30 days and compatible with SignalHF (Biotronik, Boston Scientific and Medtronic)\n* Non-activation of others HF multisensor algorithms\n* Patient remote monitored on Implicity CIED platform\n* Patient with a documented diagnosis of heart failure, eligible to reimbursement in France or Germany for HF remote monitoring\n* Patient is willing to be remotely monitored for heart failure\n* HF treated according to European Society of Cardiology (ESC) guidelines\n\nExclusion Criteria:\n\n* Patients undergoing or awaiting heart transplant or left ventricular assist device (LVAD) procedures\n* Patients with a life expectancy of less than 12 months\n* Patients enrolled in concurrent clinical studies\n* Patients with a history of non-compliance with medical care or inability to comply with the study protocol\n* Patients already receiving remote monitoring for heart failure\n* Pregnant or breastfeeding women\n* Subjects under legal protection","85 Years",{"count":86,"type":20},1132,[23],"This randomized, controlled, open-label, parallel, multicenter clinical study evaluates the efficacy of SmartSignalHF compared with heart failure (HF) remote monitoring (RM) standard of care in implanted patients with heart failure. The primary objective is to determine whether SmartSignalHF reduces all-cause mortality and HF hospitalizations at 12 months.",[28,26,27,90,91,92],"Heart Failure With Reduced Ejection Fraction (HFrEF)","Heart Failure With Decompensation","CRT and\u002For ICD","2026-03-26",{"date":95,"type":37},"2026-03-31",{"date":97,"type":37},"2025-12-19",{"date":99,"type":20},"2027-05",{"name":101,"class":44},"Implicity",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":75},"100488984","phase-1-autologous-induced-pluripotent-stem-cells-of-cardiac-lineage-for-congenital-heart-disease-100488984","NCT05647213","Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease","Safety and Feasibility of Autologous Induced Pluripotent Stem Cells of Cardiac Lineage in Subjects With Congenital Heart Disease","Individuals may be considered eligible for enrollment for Part I of this study (Skin Punch Biopsy) if in the best judgment of the Principal Investigator they will meet eligibility criteria outlined below at the time it is determined acceptable investigational product is available for administration (approximately 9 months post skin punch biopsy). Inclusion and exclusion criteria apply to both the treatment and control arms of the study unless otherwise specified.\n\nInclusion Criteria\n\nIndividuals who meet all the following criteria are eligible for enrollment as study participants:\n\n* Age 18 to 40 years old\n* Subject must be able to understand and provide informed consent.\n* Univentricular congenital heart disease.\n* End-stage systolic heart failure, defined as Class IV according to New York Heart Association (NYHA) with abnormal visually estimated ejection fraction below 40%.\n* Prognosis of 1 to 1.5 years survival at time of skin biopsy.\n* The patient falls into one of the following categories:\n\n  * Currently listed for heart transplantation at an accredited program in the US but has an expected waiting time for a suitable organ that is likely longer than anticipated life-expectancy.\n  * Has been denied access to a heart transplantation at an accredited US institution.\n  * Is currently on or planning to be on mechanical support as destination therapy.\n* All guideline directed therapy available to the subject has been maximized, for a minimum of 3 months prior to enrollment.\n* Adequate social support system that facilitates subject participation in all study required tests and procedures and supports the subject's ability to comply with long-term study requirements.\n\nExclusion Criteria\n\nIndividuals who meet any of the following criteria are not eligible for enrollment as study participants:\n\n* No available autologous iPSC-CL as defined by the manufacturer's release criteria. (This applies to Part II of the study and applies to the treatment arm only.)\n* History of symptomatic episodes of cardiac arrythmia requiring cardiac defibrillation or escalation of medications.\n* Heart failure with preserved ejection fraction.\n* Heart failure due to co-morbid conditions (e.g., amyloidosis, valvular heart disease, refractory anemia).\n* QTc greater than 500 ms.\n* Stage III or higher chronic kidney disease.\n* History of liver cirrhosis.\n* History of coronary artery disease.\n* Uncontrolled diabetes mellitus.\n* Any history of cancer.\n* Contraindication for use of amiodarone for up to 3 months (treatment arm only).\n* Contraindication for insertion of Insertable Cardiac Monitor.\n* Contraindication for placement of LifeVest cardioverter defibrillator.\n* Positive serology testing for HIV, Hepatitis B, Hepatitis C or Syphilis.\n* Obesity with BMI greater than 30.\n* Current alcohol or drug abuse precluding heart transplantation.\n* Active infection requiring ongoing treatment.\n* Contraindication to anesthesia.\n* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality of the data obtained from the study.\n* Inability or unwillingness of a participant to give written informed consent or comply with study protocol.\n* History of non-compliance.\n* Inability to be accompanied around the clock for any part of the first 3 weeks post product administration.\n* Uncontrolled depression.\n* Denied heart transplant due to social determinants.\n* Current participation in another cardiac interventional clinical trial that could confound the results of this study.\n* Previous heart transplant.","40 Years",{"count":111,"type":20},50,[113],"PHASE1","The goal of this clinical trial is to test the safety of lab-grown heart cells made from stem cells in subjects with congenital heart disease. The main questions it aims to answer are:\n\n* Is this product safe to deliver to humans\n* Is the conduct of this trial feasible\n\nParticipants will be asked to:\n\n* Agree to testing and monitoring before and after product administration\n* Receive investigational product\n* Agree to lifelong follow-up Researchers will compare subjects from the same pool to see if there is a difference between treated and untreated subjects.",[116,117,27,118],"Univentricular Heart","Congenital Heart Disease","Heart Failure NYHA Class IV",[120,121,122,123],"univentricular","heart disease","iPSC","induced pluripotent stem cell","2026-03-11",{"date":126,"type":37},"2026-03-13",{"date":128,"type":37},"2023-02-03",{"date":130,"type":20},"2029-02",{"name":132,"class":74},"HeartWorks, Inc.",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":75},"100576942","sustaining-home-heart-failure-palliative-care-in-rural-appalachia-100576942","NCT06791850","Sustaining Home Heart Failure Palliative Care in Rural Appalachia","Sustaining Home Palliative Care for Patients With Heart Failure (HF) and Their Family Caregivers in Rural Appalachia: A Mixed Methods Randomized Clinical Trial (RCT).","Inclusion Criteria:\n\n1. Adult patients' age between 50 to 80 years with advanced HF (NYHA III or IV), diagnosed by physician\n2. Caregivers' age between 45 to 80 years.\n3. Alert and consent to participate\n4. Able to read and understand English\n\nExclusion Criteria:\n\n1. Already received or are on a waiting list for a heart transplant or left ventricular assist device (LVAD)\n2. Diagnosed with a terminal illness or dementia, such as Alzheimer's disease","45 Years","80 Years",{"count":143,"type":20},208,[23],"The aim of this mixed methods randomized controlled trial is to test the integrated nurse-led intervention bundle for family home care management of end-stage heart failure and palliative care in rural Appalachia. This intervention bundle is designed to address rural disparities in access to health care, with the help of the faith-based nurses and local volunteer visiting neighbors.",[27,118],[148,149,150,151],"advanced heart failure","home palliative care","family caregiver","rural Appalachia","2026-03-05",{"date":154,"type":37},"2026-03-09",{"date":156,"type":37},"2025-04-01",{"date":158,"type":20},"2028-05-31",{"name":160,"class":74},"West Virginia University",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":141,"enrollmentInfo":168,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":75},"100623665","phase-2-optimizing-hfref-patients-using-barostim-and-cardiomems-100623665","NCT07399587","Optimizing HFrEF Patients Using BaroStim and CardioMems","Optimizing the Management of Patients With Heart Failure With Reduced Ejection Fraction Using BaroStim and CardioMems","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, ages 18-80 years\n4. Diagnosed with NYHA Class III Heart Failure with LVEF\\\u003C35%\n5. Able to tolerate oral medications for guideline directed medical therapy titration period\n6. Have undergone insertion of CardioMems and BaroStim devices per standard of care.\n7. It is a standard of care to recommend that females of reproductive potential use highly effective contraception, because of the teratogenic potential of many medications used to treat HFrEF. In addition, withdrawal of GDMT during pregnancy may reverse the positive remodeling and lead to life threatening worsening of heart failure. Women of child-bearing age need to agree to use such a method during study participation and indefinitely after the end of the study.\n\nExclusion Criteria:\n\n1. Individuals ineligible for either CardioMems or BaroStim devices.\n2. NT-proBNP \\>1600 mg\u002FdL\n3. Indicated for CRT-D device (left bundle branch block)\n4. Initial 6-minute walk test distance less than 140 m\n5. Left ventricular assist device (LVAD)\n6. History of carotid vascular procedure (carotid endarterectomy)\n7. Pregnancy or lactation\n8. Known allergic reactions to components of the BaroStim or CardioMems insertion or guideline directed medical therapy for heart failure\n9. Febrile illness within 30 days of study enrollment\n10. Treatment with another investigational drug or other intervention within 1 year\n11. Current smoker or tobacco use within 1 year\n12. Enrolled in any other CVRx funded study, including investigator-initiated research, registries, or other pre- or post-market studies.\n13. Vulnerable individuals as outlined below",{"count":5,"type":20},[170,171],"PHASE2","PHASE3","The goal of this study is to utilize CardioMems (measurement of pulmonary artery diastolic pressure) to assess BaroStim. At the time of CardioMems insertion, patients will be screened for candidacy to receive a BaroStim device. Patients will be followed for 3 months after the CardioMems insertion before undergoing insertion of a Barostim. Patients who have undergone a CardioMems, will be eligible for enrollment after 3 months of medication management and optimization. Patients will be followed for 1 year after insertion of Barostim.",[27],[175],"NYHA Class III heart failure","2026-02-02",{"date":178,"type":37},"2026-02-10",{"date":180,"type":37},"2025-01-17",{"date":182,"type":20},"2029-12-31",{"name":184,"class":74},"Northwell Health",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":195,"phases":4,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":75},"100576287","real-world-effectiveness-of-the-cordella-pulmonary-artery-sensor-system-in-patients-with-chronic-heart-heart-failure-100576287","NCT06783335","Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure","The Real-World Effectiveness of The Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Failure: A Comparative Analysis to Standard of Care Pharmacologic Therapy","LOWER-PAP","Inclusion Criteria for Cordella PA Sensor System Cohort:\n\n* Received Cordella PA Sensor System implant between 10\u002F1\u002F2024-12\u002F31\u002F2029\n* Documented chronic heart failure with NYHA Class III symptoms\n* On guideline-directed medical therapy based on ejection fraction status:\n\n  * For reduced EF (≤40%): At least one fill of ACE\u002FARB\u002FARNI, MRA, BB, or SGLT2i, and one fill of a loop diuretic\n  * For preserved EF (\\>40%): At least one fill of a loop diuretic\n* Has continuous health insurance enrollment for 12 months prior to implant\n\nInclusion Criteria for Standard of Care Control Cohort:\n\n* Two or more encounters with diagnosis codes for chronic systolic and\u002For diastolic heart failure\n* Documented ejection fraction reading within 6 months (+ or -) of second heart failure encounter\n* On guideline-directed medical therapy based on ejection fraction status:\n\n  * For reduced EF (≤40%): At least one fill of ACE\u002FARB\u002FARNI, MRA, BB, or SGLT2i, and one fill of a loop diuretic\n  * For preserved EF (\\>40%): At least one fill of a loop diuretic\n* Has continuous health insurance enrollment for 12 months prior to study entry\n\nExclusion Criteria:\n\n* No implanted pulmonary artery sensor or monitoring at any time (Standard of Care Control Cohort only)\n* Record of temporary mechanical circulatory support during baseline period\n* Diagnosis of cardiogenic shock during baseline period\n* Receiving palliative care\u002Fhospice during baseline period\n* Record of end-stage renal disease during baseline period\n* Unable to take dual antiplatelet therapy or anticoagulants for one month post implant (Cordella Cohort only)",{"count":194,"type":20},2150,"OBSERVATIONAL","This retrospective, non-randomized cohort study will evaluate how well the Cordella PA Sensor System works compared to standard medication treatment in people with chronic heart failure. The study will track patients for two years to see if those using the Cordella system have fewer deaths and hospitalizations related to heart failure.",[27,28],[199,30,200,31,201],"Heart failure","Pulmonary Artery Pressure Sensor","Cordella","2025-11-18",{"date":204,"type":37},"2025-11-19",{"date":206,"type":37},"2025-02-07",{"date":208,"type":20},"2030-12-31",{"name":43,"class":44},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":224,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":75},"100600592","reduced-functionality-and-kinesiophobia-in-patients-with-heart-failure-use-of-alternative-therapeutic-strategies-100600592","NCT07099495","REDUCED FUNCTIONALITY AND KINESIOPHOBIA IN PATIENTS WITH HEART FAILURE: USE OF ALTERNATIVE THERAPEUTIC STRATEGIES","Reduced Functionality and Kinesiophobia in Patients With Heart Failure: Use of Neuromuscular Electrical Stimulation as an Alternative Therapeutic Strategy","Inclusion Criteria:\n\n* Individuals of both sexes;\n* Age ≥ 18 years;\n* Diagnosis of chronic HF;\n* Symptoms compatible with Functional Class (FC) III-IV of the New York Heart Association (NYHA);\n* Stable condition on pharmacological therapy;\n* Absence of Acute Myocardial Infarction in the last three months prior to participant recruitment;\n* Absence of an automatic internal cardioverter defibrillator (ICD) or cardiac pacemaker;\n\nExclusion Criteria:\n\n* Individuals with hemodynamic instability, unstable angina, acute myocardial infarction during the period of application of the protocol and diagnosis of hypertrophic cardiomyopathy during the period of application of the protocol;\n* Individuals with recent muscle or tendon injuries, muscular dystrophies, myopathies, unstable fractures, infections or deep vein thrombosis (DVT);\n* Chronic need for oxygen therapy;\n* Absence in reassessments;\n* Refusal to participate in the research after its beginning.",{"count":218,"type":20},54,[23],"Introduction: Heart failure (HF) is a clinical syndrome that has advanced on a large scale concomitant with population aging and other factors. Thus, the search for alternatives that minimize the losses resulting from its structural and functional damage are important to optimize its treatments, with the primary objective of enabling the participation of these individuals in the most diverse daily tasks. Low-frequency (LF) or medium-frequency (MF) neuromuscular electrical stimulation (NMES) can be considered a resource to enable the improvement of vital and functional parameters of the population with HF intolerant to physical exercise, and it is also important to identify within these modalities which is most effective. In addition to these factors, kinesiophobia can be found in this population, and NMES can also be adopted as a strategy for kinesiophobia in these patients, with the objective of enabling the progression of behaviors. Objective: To evaluate and compare the effectiveness of LF and MF NMES on the indices of kinesiophobia and functionality in patients with HF. Methods: The research will be divided into two types of study: a double-blind randomized clinical trial (RCT) to evaluate NMES protocols, and a qualitative study with subsequent development and validation of a questionnaire to measure kinesiophobia in individuals with HF. The population included in the RCT will have their assessments (personal, socioeconomic, demographic data, Sit-to-Stand Test, kinesiological ultrasound and surface electromyography of the quadriceps muscles) conducted before their discharge from Hospital Nova Esperança (HNE), and after completion of the protocols at the same institution, in the city of João Pessoa - Paraíba. The application of NMES protocols will be carried out in the home environment (30 min\u002Fday, 3 times a week, for a total of 8 consecutive weeks). The population for the qualitative study and for the development of the questionnaire will consist of individuals diagnosed with HF of any etiology, compensated and able to perform kinesiotherapy activities, admitted to the HNE wards, between 24-48 hours before hospital discharge. An in-depth semi-structured interview will be conducted with these individuals, followed by the application of questionnaires developed based on the interviews, and the entire study will be conducted while the patients are hospitalized. Expected results: Regarding the first study, it is expected that patients treated with NMES will show improvements in clinical and functional variables, and these improvements may be more pronounced depending on the frequency applied. On the other hand, the qualitative study may reveal whether patients have fear of movement, even if they are clinically stable. The developed questionnaire will be well understood and have adequate psychometric qualities. Finally, it is expected that this knowledge can serve as a basis for optimizing the care of this patient population.",[28,27,118,222,223],"Neuromuscular Electrical Stimulation (NMES)","Kinesiophobia",[225,226,227],"heart failure","neuromuscular electrical stimulation","kinesiophobia","NOT_YET_RECRUITING","2025-07-24",{"date":231,"type":37},"2025-08-01",{"date":233,"type":20},"2025-08-18",{"date":235,"type":20},"2027-12-30",{"name":237,"class":74},"Universidade Federal do Rio Grande do Norte",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":195,"phases":4,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":75},"100596453","association-between-the-sit-to-stand-test-and-the-prognosis-of-patients-with-heart-failure-100596453","NCT07045649","Association Between the Sit-To-Stand Test and the Prognosis of Patients With Heart Failure","Association Between Performance in the 1-Minute Sit-To-Stand Test and Clinical and Functional Outcomes of Patients Hospitalized for Heart Failure - Prospective Observational Study","Inclusion Criteria:\n\n* Patients diagnosed with CDI;\n* Over 18 years of age;\n* With an Intensive Care Unit Mobility Scale (IMS) \\> 4 at discharge from the ICU;\n* Able to sit and stand up from a chair without support from the upper limbs (ULs) will be included in the study.\n\nExclusion Criteria:\n\n* Patients with cognitive alterations;\n* Level of consciousness, with \\[RASS (Richmond Agitation and Sedation Scale) \\>+1 or \\\u003C-2 and Glasgow \\\u003C13 (Coma Scale)\\], neurological and orthopedic, which compromise the understanding and performance of the assessment will be excluded;\n* Patients with advanced invasive ventilatory and circulatory support or in cardiogenic shock.",{"count":246,"type":20},68,"Introduction: Heart failure (HF), among cardiovascular diseases, is the disease that has been increasing its incidence and prevalence the most in recent years in the world population, due to the aging of the population. In addition, HF is the most frequent hospital diagnosis in the elderly, and is the main cause of hospitalization, with significant expenditure in public and private health care worldwide. Some functional tests have been used to predict the prognosis in patients with HF, however, the use of the 1-minute sit-to-stand test (SST1) to predict prognosis in HF has little scientific evidence, due to the lack of studies found in the literature for this population. Thus, the present study aims to evaluate the association between SST1 at discharge from the Cardio Intensive Care Unit (ICU) and the clinical outcome after 90 days in patients hospitalized for decompensated heart failure (DHF). Methods: This is a prospective cohort study analyzing the association between performance on the TSL1 and clinical outcome in patients hospitalized for DHF from June 2025 to October 2025. Sociodemographic, family, social, and clinical data will be collected from the participants, after which the TSL1 will be performed. The outcome of death and hospital readmission within 90 days after discharge from the ICU will be identified through telephone contact, which will be carried out by the researcher. Expected results: It is expected that from the results of this study it will be possible to understand whether performance on the TSL1 predicts clinical outcome for patients hospitalized for DHF and that it will even be possible to determine a cutoff point capable of predicting the outcomes of interest.",[28,118,249,27,26],"Heart Failure; With Decompensation",[251,252,253],"Functional Status","Hospitalization","Prognosis","2025-07-18",{"date":256,"type":37},"2025-07-23",{"date":258,"type":37},"2025-07-16",{"date":260,"type":20},"2026-02",{"name":262,"class":74},"Centro Universitário Augusto Motta",{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":21,"phases":273,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":4},"100597983","optimization-of-star-100597983","NCT07065578","Optimization of STAR","Optimization of the STAR Intervention on Self-care Symptom Management in Patients With Heart Failure","STAR","Inclusion Criteria:\n\n* Diagnosed with HF (irrespective of ejection fraction) and symptomatic NYHA class II or III.\n* 18 years or older.\n* Willing and able to provide written informed consent.\n* Life expectancy \\>6 months.\n* Optimal medical HF treatment following ESC HF guidelines (i.e. 'patients with stable HF').\n\nExclusion Criteria:\n\n* Participants living in a care facility (e.g. nursing home, revalidation center).\n* Language barrier preventing sufficient understanding and communication in Dutch.\n* Participants who are hospitalized during inclusion.",{"count":272,"type":20},320,[23],"The aim of this study is optimize the STAR (SympTom mAnagement self-caRe) intervention to support patients with HF in staying healthy, and particularly in self-monitoring and managing symptoms. The STAR intervention includes promising components aiming at improving patient outcomes in terms of interference of bothersome symptoms, self-care, quality of life (QoL) and healthcare utilization.\n\nIn this study, the intervention components are tested in an optimization trial in 320 patients with HF from 8 HF clinics in the Netherlands. This study will result in an optimized STAR intervention, composed of the best components, that is effective, scalable, and efficient to improve patient outcomes and can be used in HF clinics.",[26,27],[28,277,278,279,280],"Self-management","symptom management","Self-care","e-Health","2025-07-03",{"date":283,"type":37},"2025-07-15",{"date":285,"type":20},"2025-07",{"date":287,"type":20},"2027-03-31",{"name":289,"class":74},"UMC Utrecht",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":21,"phases":300,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":75},"100299612","baduanjin-eight-silken-movement-with-self-efficacy-building-for-patients-with-chronic-heart-failure-besmile-hf-study-100299612","NCT03180320","Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study)","Effect of an Exercise-based Cardiac Rehabilitation Program 'Baduanjin-eight-silken-movement With Self-efficacy Building' for Patients With Chronic Heart Failure in Guangzhou, China (BESMILE-HF Study)","BESMILE-HF","Inclusion Criteria:\n\n1. aged 18 years or above\n2. diagnosed with chronic heart failure\n3. clinically stable as defined as symptoms and signs that have remained generally unchanged for at least 1 month\n4. NYHA functional class II or III\n\nExclusion Criteria:\n\n1. patients who have contraindications to cardiopulmonary test\n2. patients who have contraindications to exercise training\n3. Patients who have serious acute or chronic organic disease or mental disorders\n4. history of cardiac surgery, cardiac resynchronization therapy, or intracardiac defibrillation within the previous 3 months;\n5. history of cardiac arrest within 1 year;\n6. history of peripartum cardiomyopathy, hyperthyroid heart disease, primary pulmonary hypertension;\n7. inability to perform a bicycle stress test;\n8. severe cognitive dysfunction precluding informed consent or understanding of exercise concepts;\n9. current regular Baduanjin or current participation in a conventional cardiac rehabilitation program\n10. current participation in another trial.",{"count":299,"type":20},150,[23],"Chronic heart failure (CHF) is a major and growing public health problem and poses economic burden on the society. There is a need for a safe, equipment-free, low-cost, and easily implemented exercise-based cardiac rehabilitation program for CHF patients in China. Baduanjin exercise, translated as 'eight silken movements', is one of the most common forms of traditional Chinese exercise and it could have value to be integrated into a exercise-based cardiac rehabilitation program for CHF patients, together with education, evaluation and consultancy. Accordingly, the BESMILE-HF program applying the Baduanjin exercise as the central component, has been developed in Guangdong Provincial Hospital of Chinese Medicine which is one of the largest hospitals of Chinese medicine in China. This project is to evaluate the efficacy and acceptability of BESMILE-HF program in patients with CHF in China, and it will be based on a randomized controlled trial and a qualitative study.",[26,27,28],[304,305,306],"chronic heart failure","exercise-based cardiac rehabilitation","Baduanjin","2025-05-14",{"date":309,"type":37},"2025-05-18",{"date":311,"type":37},"2018-10-22",{"date":313,"type":20},"2026-06-30",{"name":315,"class":74},"Guangdong Provincial Hospital of Traditional Chinese Medicine",{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":21,"phases":326,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":341},"100540195","comprehensive-hybrid-cardiac-rehabilitation-trial-on-heart-failure-100540195","NCT06313684","Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure","Comprehensive Hybrid Cardiac Rehabilitation Trial to Assess Impact on Heart Failure Patients","COCREATIONHF","Inclusion Criteria:\n\n* Adult patients with HF of New York Heart Association functional class II or III.\n* Meets HF diagnostic criteria of Guidelines\n* On optimal tolerated medical therapy.\n* Deemed by the treating physician as stable for at least 1 month.\n* Able to attend the health center three times a week for the first month, and twice a week for the 2nd and 3rd months\n* Owns a mobile phone\n* Patient consents to participate in the study by signing an informed consent form.\n\nExclusion Criteria:\n\n* Chronic kidney disease with glomerular filtration rate \\\u003C 20 mL\u002Fmin.\n* Decompensated thyroid disease.\n* End-stage liver failure or Child-Pugh C.\n* Cardiac device or cardiac surgery in the previous month or planned in the next 3 months.\n* Patients with dyspnea predominantly of non-cardiac cause (e.g. COPD).\n* Atrial fibrillation with a heart rate greater than 90 beats per minute at rest.\n* Active neoplasm with life expectancy \\\u003C2 years.\n* Inclusion in another interventional study.\n* Explicit contraindications to performing exercise.\n* Comorbidities that preclude the patient from engaging in a CR program.\n* Musculoskeletal or neurological disease that precludes the patient from performing exercise.",{"count":325,"type":20},152,[23],"CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.",[26,27],[330,225,331],"cardiac rehabilitation","exercise","2024-11-27",{"date":334,"type":37},"2024-12-03",{"date":336,"type":37},"2024-04-01",{"date":338,"type":20},"2027-03",{"name":340,"class":74},"Universidad de La Frontera",4,{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":350,"enrollmentInfo":351,"targetDuration":4,"studyType":21,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":4},"100523576","phase-1-narrative-intervention-for-chronic-illness--heart-failure-trial-nici-hf-100523576","NCT06097481","Narrative Intervention for Chronic Illness- Heart Failure Trial (NICI-HF)","Refining an Asynchronous Narrative-Based Intervention for Adjusting to Heart Failure Chronic Illness to Advance Behavioral Health Equity","NICI-HF","Inclusion Criteria:\n\n* Dx with Heart Failure, NYHA Class III and IV\n* Have an email address and able to check email regularly\n* Have a working phone number\n* Between the ages of 18-89 years old\n\nExclusion Criteria:\n\n* Conflicting research study","89 Years",{"count":352,"type":20},300,[113,170],"The Narrative Intervention for Chronic Illness-Heart Failure (NICI-HF) offers an asynchronous interactive text behavioral health intervention to advance behavioral health equity by facilitating access to care for people adjusting to living with heart failure (HF). The proposed study will recruit up to 70 people living with heart failure. This study will gain insight into living with heart failure and learn if the narrative-based intervention is feasible and acceptable for people living with heart failure. The study has two specific aims:\n\nAim 1: Evaluate the effects of NICI-HF intervention on standard behavioral outcomes. The study investigators will review depression with the Personal Health Questionnaire-9 (primary) and anxiety with the General Anxiety Disorder-7 (secondary) outcomes, and explore self-care with the Self Care for Heart Failure Index by comparing the sham control (n=30) and NICI-HF intervention (n=30) groups at baseline, three months, and six months.\n\nAim 2: Refine NICI-HF for feasibility and acceptability to support HF self-care and burdensome symptom management and to increase behavioral health equity by improving proximity to services. The study investigators will use standard implementation domains to tailor the intervention for HF using qualitative semi-structured interviews and mixed methods analysis. The study investigators will refine and manualize the intervention for future R01 testing across chronic illnesses with diverse and marginalized populations and service delivery models.",[28,27,118],"2024-11-11",{"date":358,"type":37},"2024-11-13",{"date":360,"type":20},"2025-09",{"date":362,"type":20},"2027-11",{"name":364,"class":74},"University of Colorado, Denver",{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":21,"phases":375,"briefSummary":376,"conditions":377,"keywords":382,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":398,"leadSponsor":400,"locationsCount":75},"100487848","atrial-appendage-micrograft-transplants-to-assist-heart-repair-after-cardiac-surgery-100487848","NCT05632432","Atrial Appendage Micrograft Transplants to Assist Heart Repair After Cardiac Surgery","Autologous Atrial Appendage Micrografts Transplanted During Coronary Artery Bypass Surgery: the AAMS2 Randomized, Double-blinded, and Placebo-controlled Trial","AAMS2","Inclusion Criteria:\n\n* Informed consent obtained\n* Left ventricular ejection fraction (LVEF) between ≥ 15% and ≤ 40% at recruitment (transthoracic echocardiography)\n* New York Heart Association (NYHA) Class II-IV heart failure symptoms\n\nExclusion Criteria:\n\n* Heart failure due to left ventricular outflow tract obstruction\n* Acute myocardial infarction (AMI) within last 30 days\n* History of life-threatening and possibly repeating ventricular arrhythmias or resuscitation, or an implantable cardioverter-defibrillator\n* Stroke or other disabling condition within 3 months before screening\n* Severe valve disease or scheduled valve surgery\n* Renal dysfunction (GFR \\\u003C45 ml\u002Fmin\u002F1.73m2)\n* Other disease limiting life expectancy\n* Contraindications for coronary angiogram or LGE-CMRI\n* Participation in some other clinical trial\n\nScreening Failure:\n\n* After optimization of medications, no visible scar or LVEF ≥ 50% in preoperative LGE-CMRI\n* Preoperative LGE-CMRI has not been performed prior scheduled CABG","75 Years",{"count":111,"type":20},[23],"Ischemic heart disease (IHD) leads the global mortality statistics. Atherosclerotic plaques in coronary arteries hallmark IHD, drive hypoxia, and may rupture to result in myocardial infarction (MI) and death of contractile cardiac muscle, which is eventually replaced by a scar. Depending on the extent of the damage, dysbalanced cardiac workload often leads to emergence of heart failure (HF).\n\nThe atrial appendages, enriched with active endocrine and paracrine cardiac cells, has been characterized to contain cells promising in stimulating cardiac regenerative healing.\n\nIn this AAMS2 randomized controlled and double-blinded trial, the patient's own tissue from the right atrial appendage (RAA) is for therapy. A piece from the RAA can be safely harvested upon the set-up of the heart and lung machine at the beginning of coronary artery bypass (CABG) surgery. In the AAMS2 trial, a piece of the RAA tissue is processed and utilized as epicardially transplanted atrial appendage micrografts (AAMs) for CABG-support therapy.\n\nIn our preclinical evaluation, epicardial AAMs transplantation after MI attenuated scarring and improved cardiac function. Proteomics suggested an AAMs-induced glycolytic metabolism, a process associated with an increased regenerative capacity of myocardium. Recently, the safety and feasibility of AAMs therapy was demonstrated in an open-label clinical study. Moreover, as this study suggested increased thickness of the viable myocardium in the scarred area, it also provided the first indication of therapeutic benefit.\n\nBased on randomization with estimated enrolment of a total of 50 patients with 1:1 group allocation ratio, the piece of RAA tissue is either perioperatively processed to AAMs or cryostored. The AAMs, embedded in a fibrin matrix gel, are placed on a collaged-based matrix sheet, which is then epicardially sutured in place at the end of CABG surgery. The location is determined by preoperative late gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI) to pinpoint the ischemic scar. The controls receive the collagen-based patch, but without the AAMs. Study blood samples, transthoracic echocardiography (TTE), and LGE-CMRI are performed before and at 6-month follow-up after the surgery.\n\nThe trial's primary endpoints focus on changes in cardiac fibrosis as evaluated by LGE-CMRI and circulating levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP). Secondary endpoints center on other efficacy parameters, as well as both safety and feasibility of the therapy.",[378,379,380,27,26,118,381],"Ischemic Heart Disease","Ischemic Cardiomyopathy","Heart Failure, Systolic","Coronary Artery Disease",[383,384,385,386,387,388,389,390,391,392,393],"Ischemic heart failure","Ischemic heart disease","Coronary artery disease","Coronary artery bypass grafting","Atrial appendage micrografts","Tissue-engineering","Ischemic cardiomyopathy","Atrial appendage","Micrografts","Cell Therapy","Epitranscriptomics","2024-04-18",{"date":396,"type":37},"2024-04-19",{"date":336,"type":37},{"date":399,"type":20},"2026-12-31",{"name":401,"class":74},"Hospital District of Helsinki and Uusimaa",{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":21,"phases":411,"briefSummary":412,"conditions":413,"keywords":415,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":75},"100250363","study-of-the-clinical-impact-of-surgical-correction-of-tricuspid-insufficiency-in-implantable-lvad-patients-100250363","NCT02537769","Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients","Randomized Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients","Inclusion Criteria:\n\n1. Participant or their legal representative has signed an informed consent\n2. Over 18 years of age\n3. Participant with advanced heart failure symptoms (Class III or IV) and preoperative mild tricuspid regurgitation who are scheduled for an implantable LVAD\n\nExclusion Criteria:\n\n1. Prior tricuspid valve repair\n2. Any evidence of structural (chordal or leaflet) tricuspid valve disease\n3. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator\n4. Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counter pulsation\n5. Body Mass Index (BMI) \\> 45\n6. Pregnancy\n7. Presence of mechanical aortic valve that will not be converted to a bioprosthesis at time of LVAD implant\n8. History of cardiac transplant or cardiomyoplasty\n9. Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAD management\n10. Presence of active, uncontrolled infection\n11. Evidence of intrinsic hepatic disease as defined by liver enzyme values\n12. History of a stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (\\> 80%) extra cranial stenosis\n13. Need for chronic renal replacement therapy (e.g. chronic dialysis)\n14. Participation in any other clinical investigation that is likely to confound study results or affect study outcome\n15. Any condition, other than heart failure, that could limit survival to less than 1 year\n16. Participant refuses to be enrolled in study\n17. Institution inmates.",{"count":410,"type":20},40,[23],"The use of implantable left ventricular assist devices (LVAD) has increased over the last decade; partly because the newer continuous flow pumps feature a smaller design and better durability. These pumps have shown improved outcomes for those patients who don't qualify for heart transplantation and receive the LVAD device as a permanent therapy or a bridge to heart transplantation. Despite these improved outcomes, procedure related length of hospitalization for LVAD implantation is still 2 or 3 times that of other heart surgery treatments. One important reason for this is that many people experience right ventricular dysfunction after LVAD implantation. Treatment options for this are limited. Many LVAD patients with right ventricular dysfunction also have tricuspid valve regurgitation (TR). This is the failure of the tricuspid valve (TV) to close completely so that blood leaks backwards. Some recent studies suggest that correction of the TV during LVAD implantation has improved survival for those with severe regurgitation. However, this has not been evaluated for mild or moderate regurgitation.\n\nThe goal of this study is to look at the clinical impact of surgical correction of mild to moderate TR in participants who are also undergoing LVAD implantation. The study will look at the degree of TR at various time points post-surgery, as well as any major cardiac adverse events, duration of hospitalization, and quality of life. The investigators hope to show that surgical correction of mild to moderate TR in LVAD patients will reduce right ventricular dysfunction and have a positive impact on health outcomes.",[414,27,118],"Tricuspid Regurgitation",[416,417,199,418,419,420,421,422],"LVAD","Tricuspid regurgitation","Transplant","3D transesophageal echocardiography (TEE)","2D transesophageal echocardiography (TEE)","Mild","Moderate","2021-02-19",{"date":425,"type":37},"2021-02-23",{"date":427,"type":4},"2015-08",{"date":429,"type":20},"2026-12",{"name":431,"class":74},"University of Washington"]