Medication Withdrawal in Stable HF With Improved LVEF

ConditionHeart Failure

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorHospital de Clinicas de Porto Alegre

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Discontinuation of MRAs
Drug
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
Drug
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.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: PlaceboPlacebo comparator 1 intervention

Group B: Continue MRAsActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Left Ventricular Ejection Fraction

Decrease from baseline in left ventricular ejection fraction (LVEF) of greater than 10%, resulting in a final LVEF below 40%.

Time frame

6 months

Change in NT-proBNP Levels

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.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital de Clinicas de Porto Alegre

Lead sponsor

Source ClinicalTrials.gov

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