Medication Withdrawal in Stable HF With Improved LVEF

NCT07489547 · tracked via the Priya Life Science Brazil tracker

Sponsor

Hospital de Clinicas de Porto Alegre

Phase

Phase 2/3

Started

2025-03-01

Last updated

2026-03-30

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Discontinuation of MRAsContinue MRAs

Discontinuation of MRAs: Participants assigned to the intervention group will undergo discontinuation of MRAs as part of a treatment simplification strategy in patients with stable heart failure with improved left ventricular ejection fraction. All other guideline-directed medical therapies will be maintained according to the treating physician's judgment. Participants will be clinically monitored during follow-up to assess stability, potential recurrence of heart failure symptoms, and other clinical outcomes after withdrawal of MRAs.

Continue MRAs: Participants assigned to the control group will continue MRAs as part of their guideline-directed medical therapy for heart failure with improved left ventricular ejection fraction. All other heart failure medications will be maintained according to standard clinical practice and the treating physician's judgment. Participants will be clinically monitored during follow-up to assess clinical stability, heart failure symptoms, and other relevant outcomes.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

Change in Left Ventricular Ejection Fraction — 6 months
Decrease from baseline in left ventricular ejection fraction (LVEF) of greater than 10%, resulting in a final LVEF below 40%.
Change in NT-proBNP Levels — 6 months
Increase from baseline in NT-proBNP levels of greater than 50%, with age-specific cut-off values: 450 pg/mL for participants younger than 50 years, 900 pg/mL for those between 50 and 75 years, and 1800 pg/mL for participants older than 75 years.

Trial sites (1)

Facility	City	Region	Status
Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07489547 on ClinicalTrials.gov ↗ ← All trials in Brazil