Simplification of Treatment by Withdrawal of Medications in Stable Heart Failure With Improved Left Ventricular Ejection Fraction
Simplifying Heart Failure Treatment
Plain English Summary
Medication Withdrawal in Stable HF With Improved LVEF is a Phase 3 clinical trial sponsored by Hospital de Clinicas de Porto Alegre studying Heart Failure. Evaluates if stopping a specific heart medication is safe and effective for patients with improved heart function. For patients with stable heart failure who have seen improvement in heart function and are currently taking certain medications. Participation involves attending clinic visits, blood tests, and monitoring for heart function over 24 weeks. Alternative treatments include continuing the current medications or switching to other heart failure management strategies. The trial aims to enroll 90 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible if diagnosed with heart failure, using MRAs and other heart medications for at least a year, and have improved heart function. Not eligible if had a heart attack in the last year, arrhythmia requiring treatment, or severe heart valve issues. Must be at least 18 years old and have a left ventricular ejection fraction of at least 40%. Healthy enough to participate in regular medical visits and tests. This trial is studying Heart Failure, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The trial measures if stopping the medication leads to a worsening of heart function, helping patients understand if they can safely stop taking it. The specific primary outcome measures are: Change in Left Ventricular Ejection Fraction (6 months); Change in NT-proBNP Levels (6 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial aims to fill a gap in treatment options for patients with improved heart function, potentially simplifying medication regimens. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Heart Failure, where improved treatment options are needed.
Investor Insight
The market for heart failure treatments is large, with many patients needing simplified treatment options, making this trial significant. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if you meet the eligibility criteria and if stopping the medication could be safe for you. You will attend clinic visits every 6 weeks, have blood tests, and be monitored for heart function. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 90 participants
Interventions
- DRUG: 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 with
- DRUG: 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.
Primary Outcomes
- Change in Left Ventricular Ejection Fraction (6 months)
- Change in NT-proBNP Levels (6 months)
Full Eligibility Criteria
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)
Trial Locations
- Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil
Frequently Asked Questions
What is clinical trial NCT07489547?
NCT07489547 is a Phase 3 INTERVENTIONAL study titled "Medication Withdrawal in Stable HF With Improved LVEF." It is currently recruiting and is sponsored by Hospital de Clinicas de Porto Alegre. The trial targets enrollment of 90 participants.
What conditions does NCT07489547 study?
This trial investigates treatments for Heart Failure. The primary condition under study is Heart Failure.
What treatments are being tested in NCT07489547?
The interventions being studied include: Discontinuation of MRAs (DRUG), Continue 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 with
What does Phase 3 mean for NCT07489547?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07489547?
This trial is currently "Recruiting." It started on 2025-03-01. The estimated completion date is 2026-12-31.
Who is sponsoring NCT07489547?
NCT07489547 is sponsored by Hospital de Clinicas de Porto Alegre. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07489547?
The trial aims to enroll 90 participants. The trial is currently recruiting and accepting new participants.
How is NCT07489547 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07489547?
The primary outcome measures are: Change in Left Ventricular Ejection Fraction (6 months); Change in NT-proBNP Levels (6 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07489547 being conducted?
This trial is being conducted at 1 site, including Porto Alegre, Rio Grande do Sul (Brazil).
Where can I find official information about NCT07489547?
The official record for NCT07489547 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07489547. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07489547 testing in simple terms?
Evaluates if stopping a specific heart medication is safe and effective for patients with improved heart function. For patients with stable heart failure who have seen improvement in heart function and are currently taking certain medications.
Why is this trial significant?
This trial aims to fill a gap in treatment options for patients with improved heart function, potentially simplifying medication regimens. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07489547?
Potential risks include a possible worsening of heart function or increased levels of a heart failure marker. Side effects are monitored closely, and you will be given medical care if needed. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07489547?
Ask your doctor if you meet the eligibility criteria and if stopping the medication could be safe for you. You will attend clinic visits every 6 weeks, have blood tests, and be monitored for heart function. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07489547 signal from an investment perspective?
The market for heart failure treatments is large, with many patients needing simplified treatment options, making this trial significant. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves attending clinic visits, blood tests, and monitoring for heart function over 24 weeks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.