Withdrawal of Heart Failure Treatment Patients With Non-ischemic Cardiomyopathy Who Have Been Super-responders to Cardiac Resynchronization Therapy.
Key facts
- Where
- Barcelona, Girona, Granada, and L'Hospitalet de Llobregat, SpainSee the 4 sites
- Phase
- Phase 4
Where in Spain
- Hospital Vall d'HebronBarcelona, SpainTaking people
- Hospital TruetaGirona, SpainTaking people
- Hospital Virgen de las NievesGranada, SpainTaking people
- Hospital Universitari de BellvitgeL'Hospitalet de Llobregat, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institut d'Investigació Biomèdica de Bellvitge
- Trial code
- NCT07851779EU 2025-521780-12-00
- Record updated
- 1 October 2026
- Original description
Multicenter, prospective, non-inferiority, randomized, single-blind (primary endpoint evaluators blinded, patients not blinded) clinical trial.Read full original descriptionShow less
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.
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.
Inclusion: Diagnosis of non-ischemic cardiomyopathy; LBBB already present at the time of first diagnosis of LV dysfunction; Negative genetic test; Cardiac MRI with no evidence of late gadolinium enhancement (LGE at RV insertion points is acceptable); Carrier of a resynchronization device (ICD or pacemaker, with LV epicardial pacing form a cardiac vein or left bundle area pacing), pacing percentage >95% and paced QRS <140 ms; Device indication: LVEF ≤35% and LBBB with QRS >150 ms; LVEF ≥50% and normal indexed LV volumes on echocardiogram performed at least 6 months after CRT implantation; No heart failure decompensations (no hospitalizations or urgent/day hospital visits) since CRT implantation; No need for loop diuretic treatment; NYHA class I or II; NT-proBNP <450 ng/L (or <1000 ng/L in atrial fibrillation/flutter); On neurohormonal therapy with at least two drugs.
Exclusion: CRT devices implanted as an upgrade from prior pacemaker or ICD, where prior pacing percentage was >20%; Severe valvular heart disease; History of sustained ventricular arrhythmia or treated by ICD; Need to maintain beta-blocker therapy for other arrhythmias; Hypertension not controlled with other medications; Clinical indication other than heart failure to maintain any of the neurohormonal treatment drugs (class I recommendation in ESC or ACC/AHA guidelines); Family history of non-ischemic cardiomyopathy with LVEF <50% in at least one first-degree relative.