Heart failure drug withdrawal trial aims to free patients from lifelong pills
NCT ID NCT06128980
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether heart failure patients who fully recover after treatment for a fast heart rhythm (like atrial fibrillation) can safely stop their heart failure medications. 348 participants will be randomly assigned to either gradually stop their drugs or continue them as usual. The goal is to see if stopping drugs is as good as continuing them at preventing heart failure from coming back, while reducing side effects and costs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sequential weaning of heart failure medications (SGLT2i, MRA, BB, ACEi/ARB/ARNi)
- What this could lead to
- If successful, this could allow many heart failure patients who recover after treating a fast heart rhythm to safely stop some or all of their heart failure drugs, reducing side effects and medication burden.
- What could go wrong
- This is a Phase 2/3 trial with 348 patients, so results are not yet proven. There is a risk that stopping medications could lead to heart failure relapse, and the findings may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 348 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jan 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients with new onset heart failure (ambulatory or hospital) with reduced ejection fraction (LVEF≤40% assessed by echocardiography) and NYHA ≥2 and atrial fibrillation or atrial flutter with ventricular rate ≥110 bpm (ECG monitoring, hospital telemetry or Holter monitoring) that following GDMT - while AF is terminated (e.g. ablation or conversion) or controlled (HR\<110 on resting ECG) - experience LVEF remission (LVEF ≥50%), normalization of indexed LV volume, and normal ECG (no bundle branch block, ST segment deviations or T-wave inversion) and NT-proBNP \<250 pg/ml. Exclusion Criteria: * 18 years or older and able to consent * Former ablation procedures and inability to tolerate antiarrhythmic drugs * Pregnancy * Congenital heart disease (congenital defects with no hemodyamic effects are not excluded) * Previously genotyped positive for genes known to cause cardiomyopathy * Probable hypertrophic, restrictive or non-compaction cardiomyopathy * Moderate/severe valvular disease * Suspicion of or known cardiac amyloidosis, sarcoidosis, or other storage/inflammatory disease * More than 10% PVCs or documented sustained ventricular arrhythmias * History of persistent or permanent AF with ventricular rates \>110 before incident HF despite best standard of care * eGFR \< 30 ml/min/1.73 m2 * Acute myocardial infarction at index * Probable medication-, alcohol- or illicit drug use induced AF and/or HF * Systolic blood pressure \>160 mmHg (at multiple measurements) at index or history of uncontrollable hypertension * Myocarditis * Cardiogenic shock at index * Aborted sudden cardiac death * Pacing-induced cardiomyopathy * 1.st degree relative with DCM
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Herlev-Gentofte Hospital
RECRUITINGCopenhagen, 2730, Denmark
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- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Stroke's hidden heart rhythm clue under investigation