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Withdrawal of Heart Failure Treatment Patients With Non-ischemic Cardiomyopathy Who Have Been Super-responders to Cardiac Resynchronization Therapy.

Sponsor: Institut d'Investigació Biomèdica de Bellvitge • ClinicalTrials.gov ID: NCT07851779

Registry updated: 2026-10-01

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Description

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.

Interventions

Withdrawal of Heart failure medications (Drug)
Heart failure drugs will be withdrawn progressively over a maximum of 9 weeks, discontinuing drugs one by one following a predefined sequence

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * Family history of non-ischemic cardiomyopathy with LVEF \<50% in at least one first-degree relative * 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 * CRT devices implanted as an upgrade from prior pacemaker or ICD, where prior pacing percentage was \>20% * Clinical indication other than heart failure to maintain any of the neurohormonal treatment drugs (class I recommendation in ESC or ACC/AHA guidelines)

Conditions

Non-ischemic Cardiomyopathy Cardiac Resynchronisation Therapy (CRT)

Locations

Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Vall d'Hebron — Barcelona, Spain
Hospital Trueta — Girona, Spain
Hospital Virgen de las Nieves — Granada, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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