Status:
RECRUITING
Withdrawal of Treatment for Heart Failure Patients With Recovery From Tachycardia-induced Cardiomyopathy
Lead Sponsor:
Herlev and Gentofte Hospital
Collaborating Sponsors:
Nordsjaellands Hospital
University Hospital Bispebjerg and Frederiksberg
Conditions:
Heart Failure With Reduced Ejection Fraction
Heart Rhythm Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 guidel...
Detailed Description
Background: Heart failure (HF) is a disease that affects more than 60000 patients in Denmark and millions across the world. The prognosis of HF is comparable to many types of cancer. New onset HF is ...
Eligibility Criteria
Inclusion
- 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) within 3 months after GDMT.
Exclusion
- 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 \< 40 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
Key Trial Info
Start Date :
January 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2032
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT06128980
Start Date
January 9 2025
End Date
January 1 2032
Last Update
January 13 2025
Active Locations (1)
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1
Herlev-Gentofte Hospital
Copenhagen, Denmark, 2730