Weaning heart failure treatment for patients recovering from tachycardia-induced cardiomyopathy
Withdrawal of Pharmacological Treatment for Heart Failure Patients With Recovery From Tachycardia-induced Cardiomyopathy - WEAN-HF
PHASE2; PHASE3 · Herlev and Gentofte Hospital · NCT06128980
This study is testing if slowly reducing heart failure medications is just as effective as keeping patients on full treatment after they’ve recovered from tachycardia-induced cardiomyopathy.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 348 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev and Gentofte Hospital (other) |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06128980 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the management of heart failure patients who have recovered from tachycardia-induced cardiomyopathy after controlling their atrial fibrillation. It aims to determine if gradually reducing guideline-directed medical therapy (GDMT) is as effective as maintaining full treatment in patients who have shown significant cardiac recovery. The study is designed as an open-label, randomized, non-inferiority trial, focusing on patients with reduced ejection fraction and persistent atrial fibrillation. By assessing the outcomes of weaning off medications, the trial seeks to minimize potential side effects and improve the quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults with new onset heart failure and reduced ejection fraction who have experienced recovery after treatment for atrial fibrillation.
Not a fit: Patients with congenital heart disease or those who have previously been genotyped for cardiomyopathy-related genes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and less burdensome treatment regimens for heart failure patients recovering from tachycardia.
How similar studies have performed: While there is limited data on this specific approach, similar studies have shown promise in managing heart failure through tailored medication strategies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen
- Herlev-Gentofte Hospital — Copenhagen, Denmark (RECRUITING)
Study contacts
- Principal investigator: Emil Wolsk, MD — Herlev and Gentofte Hospital
- Study coordinator: Emil Wolsk, MD
- Email: emil.wolsk@regionh.dk
- Phone: +4538683868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure With Reduced Ejection Fraction, Heart Rhythm Disorder