[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ventricular-dysfunction-left\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ventricular-dysfunction-left":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100639301","phase-4-stepwise-de-escalation-and-optimizing-withdrawal-of-arni-and-sglt2i-in-normalized-heart-failure-100639301",false,"NCT07631156","STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure","STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure (STEP-DOWN HF Trial)","STEP-DOWN HF","Inclusion Criteria:\n\n* Adults aged 19 years or older\n* Prior left ventricular ejection fraction (LVEF) ≤40% before surgery or intervention, with recovery to ≥50% (normalized range) at the time of enrollment\n* N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\\u003C250 ng\u002FL\n* Complete correction of a reversible underlying cause of heart failure: surgical or transcatheter correction of valvular heart disease (mitral regurgitation, aortic stenosis, aortic regurgitation), or percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for ischemic cardiomyopathy\n* Currently receiving both ARNI and SGLT2i for at least 3 months at enrollment (MRA and\u002For beta-blocker may also be used)\n* Clinically stable outpatient with no heart failure-related hospitalization within the prior 6 months\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Heart failure due to irreversible etiology (e.g., idiopathic dilated cardiomyopathy, toxic cardiomyopathy, genetic cardiomyopathy)\n* For valvular disease: moderate or greater paravalvular leak, or residual moderate or greater mitral or aortic regurgitation\n* For ischemic disease: incomplete revascularization or graft occlusion on post-operative coronary CT\n* Chronic kidney disease stage 4 or higher (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²)\n* Symptomatic hypotension (systolic blood pressure \\\u003C90 mmHg) or symptomatic bradycardia (heart rate \\\u003C50 beats\u002Fmin)\n* Pregnant, suspected pregnancy, or breastfeeding\n* Terminal malignancy or end-stage organ failure with life expectancy \\\u003C12 months\n* Participation in another clinical trial within 3 months prior to screening\n* Any condition that, in the investigator's judgment, makes the participant unsuitable for the study","ALL","19 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This is a multicenter, randomized, open-label pilot study to evaluate whether stepwise withdrawal of two heart failure medications-angiotensin receptor-neprilysin inhibitor (ARNI) and sodium-glucose cotransporter-2 inhibitor (SGLT2i)-is safe in patients with Heart Failure with improved Ejection Fraction (HFimpEF) whose underlying structural cause (valvular heart disease or ischemic cardiomyopathy) has been completely corrected by surgery or intervention.\n\nEighty adult patients (40 per arm) whose left ventricular ejection fraction (LVEF) has recovered to 50% or higher and whose NT-proBNP is ≤ 250 ng\u002FL will be randomized 1:1 to either (1) stepwise withdrawal of ARNI followed by SGLT2i over one month under close echocardiographic monitoring, or (2) continuation of their current guideline-directed medical therapy.\n\nThe primary outcome is the change in LVEF at 12 months, with non-inferiority of the withdrawal strategy declared if the LVEF decline is within 5 percentage points of the continuation arm. Secondary outcomes include cardiovascular death, heart failure hospitalization, NT-proBNP, quality of life (KCCQ-12), 6-minute walk distance, and adverse events.\n\nResults from this pilot will inform the design and sample size of a subsequent definitive non-inferiority trial and may provide initial evidence to guide deprescribing decisions in clinical practice.",[27,28,29],"Heart Failure With Reduced Ejection Fraction","Heart Failure","Ventricular Dysfunction, Left",[31,32,33,34,35,36,37,38],"HFimpEF","ARNI","Sacubitril\u002FValsartan","SGLT2 Inhibitor","Guideline-Directed Medical Therapy","Reverse Remodeling","Valvular Heart Disease","Ischemic Cardiomyopathy","NOT_YET_RECRUITING","2026-06-21",{"date":42,"type":43},"2026-06-24","ACTUAL",{"date":45,"type":21},"2026-06-30",{"date":47,"type":21},"2029-12-30",{"name":49,"class":50},"Kyungsub Song","OTHER",5,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":74,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100589079","flecainide-in-idiopathic-premature-ventricular-contractions-and-related-cardiomyopathy-100589079","NCT06949748","Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy","UNIFLECA Study: Prospective Cohort Study on Flecainide's Impact on Persistent High Premature Ventricular Contraction Burden and PVC-Induced Cardiomyopathy","UNIFLECA","Inclusion Criteria:\n\n* Frequent idiopathic PVCs (burden \\>5% on multiple 24-hour Holter ECG recordings)\n* Normal cardiac structure and function on echocardiography\n* No late gadolinium enhancement or myocardial scar on cardiac MRI\n* Normal coronary angiography (excluding ischemic cardiomyopathy)\n* Normal serum electrolytes and renal function\n* Willingness to comply with follow-up schedule and drug titration\n\nExclusion Criteria:\n\n* Structural heart disease\n* Ischemic heart disease (confirmed by angiography)\n* History of sustained ventricular arrhythmias\n* Left ventricular ejection fraction (LVEF) \\\u003C40% at baseline\n* Brugada syndrome, long QT syndrome, or other channelopathies\n* Contraindications to class IC agents\n* Use of concurrent antiarrhythmics or proarrhythmic drugs",true,"18 Years",{"count":63,"type":21},300,"OBSERVATIONAL","The UNIFLECA study is a prospective, single-arm, observational cohort evaluating the efficacy, safety, and tolerability of flecainide (in the form of Sanocard) in adults with frequent idiopathic premature ventricular contractions (PVCs) and suspected PVC-induced cardiomyopathy (PVCi-CMP). Frequent PVCs-defined as a burden \\>5% on two separate 24-hour Holter recordings-are increasingly recognized as a cause of reversible systolic dysfunction in patients without structural heart disease.\n\nParticipants undergo a comprehensive baseline evaluation including echocardiography, occasionally cardiac MRI, and coronary angiography or equivalent testing to confirm the absence of structural abnormalities. Patients are enrolled only if they are ineligible or unwilling to undergo catheter ablation, and have no contraindications to flecainide.\n\nFlecainide therapy is initiated at a starting dose of 100 mg\u002Fday and titrated up to 200 mg\u002Fday, guided by ECG findings, symptom response, and QRS duration. Regular follow-up occurs at three-month intervals over three years, with periodic 24-hour Holter monitoring and assessment of symptoms, LVEF, and adverse events.\n\nThe primary outcome is the reduction in PVC burden. Secondary outcomes include improvement in LVEF, symptom relief (measured by structured questionnaires), adverse effects, and long-term treatment adherence. The study aims to generate real-world data on the non-invasive management of PVCs with flecainide and explore its role as an alternative to ablation in carefully selected patients.",[67,68,69,70,29,71,72,73],"Premature Ventricular Beats","Premature Ventricular Complexes","Premature Ventricular Contraction (PVC)","Arrhythmia Ventricular","Ventricular Dysfunction","Cardiomyopathies, Secondary","Cardiomyopathies",[75,76,58,77,78,79,80,81],"Flecainide","Sanocard","PVC induced CMP","PVC","Premature Ventricular Contraction","Outflow Tract PVC","NonOutflow Tract PVC","RECRUITING","2025-06-27",{"date":85,"type":43},"2025-07-02",{"date":87,"type":43},"2024-04-26",{"date":89,"type":21},"2027-12-01",{"name":91,"class":50},"University of Athens",6,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100499499","phase-4-prophylactic-frequent-premature-ventricular-complexes-suppression-on-left-ventricular-function-impairment-in-asymptomatic-patients-100499499","NCT05784051","Prophylactic Frequent Premature Ventricular complexeS sUPPression on Left ventriculaR Function impairmEnt in aSymptomatic patientS","SUPPRESS","Inclusion Criteria:\n\nInclusion criteria (all must be present):\n\n1. 18 ≤ Age ≤ 85\n2. PVC burden ≥ to 10% regardless of current or preexisting antiarrhythmic drug intake (for instance, a patient under betablocker therapy because of his PVCs or hypertension can be included)\n3. Asymptomatic status\n4. Normal (\\>or= 55%) LVEF. Patients with underlying cardiomyopathy can be included as long as LV function remains preserved.\n5. Signed informed consent\n\nExclusion criteria (any of them):\n\n1. Pregnant woman or Female of childbearing potential without effective method of birth control or nursing woman.\n2. Patients that can't undergo MRI study\n3. De novo requirement for antiarrhythmic drug prescription for another indication (e.g. atrial fibrillation…)\n4. The physician already decided that the patient requires drug initiation or escalation;\n5. Ischemic cardiomyopathy requiring revascularization (PCI or surgery)\n6. History of LV dysfunction\n7. Participation in another research involving the human person\n8. Patient under legal protection\n9. Non affiliation to a social security scheme","85 Years",{"count":102,"type":21},298,[24],"The main objective of the study is to demonstrate that prophylactic treatment of patients with asymptomatic frequent (\\>10%) PVCs is superior to simple follow-up strategy with no therapy to prevent subsequent LV dysfunction at 24 months. The prophylactic treatment is based on drugs ± ablation (ablation can be performed if the PVC burden remain \\>10% after 2 lines of AAD treatment since the initiation of the study).\n\nThe primary endpoint will be the development of LV dysfunction (PVC-iCMP) defined as a 15% relative LVEF decrease (and\u002For a LVEF \\\u003C50%) within 2 years following randomization, on cardiac magnetic resonance imaging (cMRI) (or transthoracic echocardiography (TTE) when not possible).",[106,29],"Premature Ventricular Contractions","2023-09-05",{"date":109,"type":43},"2023-09-06",{"date":111,"type":21},"2023-10-01",{"date":113,"type":21},"2027-06-01",{"name":115,"class":50},"Assistance Publique - Hôpitaux de Paris"]