Phase 4Recruiting
Withdrawal of Heart Failure Treatment Patients With Non-ischemic Cardiomyopathy Who Have Been Super-responders to Cardiac Resynchronization Therapy. (DRUGLESS-CRT)
Withdrawal of Heart Failure Treatment in Patients With Non-ischemic Cardiomyopathy, Without Late Gadolinium Enhancement and With a Negative Genetic Test, Who Have Been Super-responders to Cardiac Resynchronization Therapy.
- Sponsor
- Institut d'Investigació Biomèdica de Bellvitge (Academic or other)
- Enrolment
- 64 planned
- Conditions
- Non-ischemic Cardiomyopathy; Cardiac Resynchronisation Therapy (CRT)
- Interventions
- Withdrawal of Heart failure medications
- Ages
- adults, older adults
- Registry
- NCT07851779
From the registry
Multicenter, prospective, non-inferiority, randomized, single-blind (primary endpoint evaluators blinded, patients not blinded) clinical trial. We aim to evaluate if the withdrawal of heart failure treatment is safe in patients with non-ischemic cardiomyopathy, negative genetic test, no evidence of late gadolinium enhancement on cardiac MRI, who have been super-responders to cardiac resynchronization therapy and remain free of heart failure events for at least 6 months after device implantation.
Primary outcomes
- Recurrence of left ventricular dysfunction or heart failure symptoms at 6 months