Medication Withdrawal in Stable HF With Improved LVEF

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Heart Failure

In brief

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 blood samples for NT-proBNP measurement at each visit; Provide one blood sample for genetic analysis of polymorphisms related to the renin-angiotensin-aldosterone system; Receive either continued MRA therapy or placebo as part of a double-blind randomized design; Be monitored for clinical stability, symptoms of heart failure, and potential adverse events during follow-up.

Key facts

Study ID: NCT07489547
Run by: Hospital de Clinicas de Porto Alegre
People needed: 90
Starts: 2025-03-01
Expected to finish: 2026-12-31
Last updated by the study team: 2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)

Full record on ClinicalTrials.gov

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