Life sciences · Phase 4 Trial
ClinicalTrials.gov · October 1, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT07851779). This is a study registration, not published results. Lead sponsor: Institut d'Investigació Biomèdica de Bellvitge. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 64 participants (ESTIMATED). Conditions: Non-ischemic Cardiomyopathy, Cardiac Resynchronisation Therapy (CRT). Interventions: DRUG: Withdrawal of Heart failure medications. Primary outcome measures: Recurrence of left ventricular dysfunction or heart failure symptoms at 6 months , 6 months. Brief summary: 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.