Actively Recruiting
Medication Withdrawal in Stable HF With Improved LVEF
Led by Hospital de Clinicas de Porto Alegre · Updated on 2026-03-30
90
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Medication Withdrawal in Stable HF With Improved LVEF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of heart failure and use of mineralocorticoid receptor antagonists and an ACE inhibitor, ARB, or ARNI for at least 12 months
- Left ventricular ejection fraction of 40% or higher, improved from a prior value of 35% or lower, with a sustained absolute increase greater than 10%
- Left ventricular end-diastolic diameter within normal limits (≤59 mm for men and ≤53 mm for women)
- New York Heart Association (NYHA) functional class I or II
- BNP levels less than 100 pg/mL, or NT-proBNP levels within age-adjusted thresholds: ≤450 pg/mL for individuals under 50 years, ≤900 pg/mL for those 50-75 years, and ≤1800 pg/mL for individuals over 75 years
- For atrial fibrillation cases, NT-proBNP thresholds should be doubled
- Clinical stability with no hospitalizations or need for increased diuretic therapy due to congestion within the previous 12 months
- Optimized heart failure medications with no changes for at least 3 months
- Maximum allowed dose of furosemide of 80 mg/day
- Acceptable heart failure causes including post-cardiac resynchronization therapy, non-ischemic causes like myocarditis, tachycardiomyopathy, alcoholic cardiomyopathy, cardiotoxicity, peripartum cardiomyopathy, corrected valvular disease, and ischemic heart failure after revascularization
You will not qualify if you...
- Acute coronary syndrome within the past 12 months
- Arrhythmia requiring therapy within the past 12 months
- Syncope or appropriate device therapy if an implantable cardioverter defibrillator (ICD) is present within the past 12 months
- Moderate to severe valvular heart disease that has not been corrected
- Severe unrevascularized coronary artery disease defined as greater than 50% narrowing of the left main coronary artery or greater than 70% narrowing of the left anterior descending, circumflex, or right coronary arteries
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
Research Team
L
Lucas C Petersen, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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