Weaning heart failure treatment for patients recovering from tachycardia-induced cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.