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Medication Withdrawal in Stable HF With Improved LVEF

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllHospital de Clinicas de Porto Alegre
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate the safety and feasibility of withdrawing mineralocorticoid antagonists (MRA) in patients with stable heart failure with improved left ventricular ejection fraction (HFimpEF). The main questions it aims to answer are: Does withdrawal of MRAs lead to a reduction in left ventricular ejection fraction greater than 10%, resulting in a final LVEF below 40%? Does withdrawal of MRAs cause a relative increase in NT-proBNP levels greater than 50% above age-adjusted thresholds? Researchers will compare MRAs withdrawal (placebo) with continuation of therapy to determine whether medication withdrawal can be performed safely without worsening heart failure status. Participants will: Attend scheduled clinical visits over a 24-week follow-up period; Undergo echocardiographic evaluation of left ventricular ejection fraction before study visits; Provide b

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of heart failure (HF) and use of MRAs and an ACE inhibitor/ARB/ARNI for at least 12 months * Left ventricular ejection fraction (LVEF) ≥40%, improved from a prior value ≤35%, with a sustained absolute increase \>10% * Left ventricular end-diastolic diameter within normal limits according to predefined criteria (≤59 mm for men and ≤53 mm for women) * NYHA functional class I or II * BNP levels \<100 pg/mL, or NT-proBNP levels within age-adjusted thresholds: ≥450 pg/mL for individuals \<50 years, ≥900 pg/mL for those 50-75 years, and ≥1800 pg/mL for individuals \>75 years * In cases of atrial fibrillation, NT-proBNP thresholds should be doubled * Clinical stability defined as no hospitalizations or need for increased diuretic therapy due to congestion within the previous 12 months * Optimized heart failure medications with no modifications for at least 3 months * Maximum allowed dose of furosemide of 80 mg/day * Acceptable etiologies: HF following cardiac resynchronization therapy (CRT); non-ischemic HF after myocarditis; non-ischemic HF due to tachycardiomyopathy; non-ischemic HF due to alcoholic cardiomyopathy; non-ischemic HF due to cardiotoxicity; non-ischemic HF due to peripartum cardiomyopathy; non-ischemic HF after correction or intervention for valvular disease; ischemic HF after revascularization Exclusion Criteria: * Acute coronary syndrome within the past 12 months * Arrhythmia requiring therapy within the past 12 months * Syncope or appropriate device therapy (if ICD present) within the past 12 months * Uncorrected moderate to severe valvular disease * Severe unrevascularized coronary artery disease, defined as \>50% stenosis of the left main coronary artery (LMCA) or \>70% stenosis of the left anterior descending artery (LAD), circumflex artery (LCx), or right coronary artery (RCA)
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What it tests

  • Discontinuation of MRAs
  • Continue MRAs
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Where

1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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