Actively Recruiting
Withdrawal of Treatment for Heart Failure Patients With Recovery From Tachycardia-induced Cardiomyopathy
Led by Herlev and Gentofte Hospital · Updated on 2026-02-23
348
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
Sponsors
H
Herlev and Gentofte Hospital
Lead Sponsor
N
Nordsjaellands Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
New onset heart failure (HF) is observed in up to 25% of patients with incident atrial fibrillation or flutter (AF). Current guidelines suggest that both conditions (AF \& HF) be addressed with guideline directed medical therapy (GDMT) for HF and rate or rhythm control of AF. Hence, patients with both conditions are subjected to extensive polypharmacy with possible prognostic benefits, but also possible side effects, such as decreased renal function, dizziness, tiredness and hypotension, as well as the financial burden on both the individual patients and society, in addition to the stigma of having a HF diagnosis. Guidelines do not inform how to manage long-term patients with HF, who following control of the incident tachycardia (e.g. AF), show full recovery from their HF condition. This investigator-initiated, open-label, randomized, non-inferiority trial will test whether incremental weaning of GDMT in patients following full cardiac recovery and AF control is non-inferior compared to continuous GDMT with respect to the primary endpoint of freedom from heart failure deterioration. Furthermore, this study seeks to extensively phenotype these patients (genetic testing, advanced imaging, biomarkers etc.) in order to establish whether certain phenotypes are at lesser or greater risk of deterioration once remission is established. This novel approach of a personalized treatment regimen depending on e.g. genetic profiling could lead to an aggressive treatment in patients at high risk of deterioration and conversely spare patients with a negligible risk, a life-long intensive treatment regimen. All HF clinics located in Zealand, Denmark, with a catchment area of \>2 million citizens, have agreed to participate in the WEAN-HF trial. A total of 348 patients will be randomized. Patients are followed up the 1st year after randomization with clinical examination, biomarkers and echocardiography, and are subsequently followed via Danish nationwide registries for 10 years.
CONDITIONS
Official Title
Withdrawal of Treatment for Heart Failure Patients With Recovery From Tachycardia-induced Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with new onset heart failure with reduced ejection fraction (LVEF 6440% by echocardiography) and NYHA class 2 or higher
- Atrial fibrillation or atrial flutter with ventricular rate 64110 bpm
- Following guideline directed medical therapy with AF terminated or controlled (heart rate <110 on resting ECG)
- Experience LVEF remission (LVEF 6450%), normalization of left ventricular volume, normal ECG, and NT-proBNP <250 pg/ml
- Age 18 years or older
You will not qualify if you...
- Former ablation procedures with inability to tolerate antiarrhythmic drugs
- Pregnancy
- Congenital heart disease except defects with no hemodynamic effects
- Previously genotyped positive for genes causing cardiomyopathy
- Probable hypertrophic, restrictive, or non-compaction cardiomyopathy
- Moderate or severe valvular disease
- Suspicion or known cardiac amyloidosis, sarcoidosis, or other storage/inflammatory disease
- More than 10% premature ventricular contractions or sustained ventricular arrhythmias
- History of persistent or permanent AF with ventricular rates >110 before incident HF despite best care
- Estimated glomerular filtration rate <30 ml/min/1.73 m2
- Acute myocardial infarction at index
- Probable medication-, alcohol-, or illicit drug-induced AF or HF
- Systolic blood pressure >160 mmHg at multiple measurements or uncontrollable hypertension
- Myocarditis
- Cardiogenic shock at index
- Aborted sudden cardiac death
- Pacing-induced cardiomyopathy
- First degree relative with dilated cardiomyopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Herlev-Gentofte Hospital
Copenhagen, Denmark, 2730
Actively Recruiting
Research Team
E
Emil Wolsk, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here