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.
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)
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
Parallel
Withdrawal of Heart failure medications
DrugHeart failure drugs will be withdrawn progressively over a maximum of 9 weeks, discontinuing drugs one by one following a predefined sequence
Recurrence of left ventricular dysfunction or heart failure symptoms at 6 months
Any of the following events: * Decrease in LVEF \>10% and final LVEF \<50% * Decrease in LVEF \>10% and increase in LV end-systolic volume \>15% * Appearance of heart failure symptoms accompanied by elevated NT-proBNP requiring initiation of oral, subcutaneous, or intravenous loop diuretic treatment.
Emergency room or day hospital visits for heart failure
Hospitalizations due to heart failure
Ventricular arrhythmias
Sustained ventricular tachycardia, sudden cardiac death, appropriate ICD therapy
Supraventricular arrhythmias
Sustained supraventricular arrhythmia, including sustained atrial fibrillation, sustained atrial flutter and sustained atrial tachycardia
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Institut d'Investigació Biomèdica de Bellvitge
Lead sponsor
University Hospital Virgen de las Nieves
Collaborator
Hospital de Sant Pau
Collaborator
Hospital Vall d'Hebron
Collaborator
Hospital Universitario La Paz
Collaborator
Hospital Universitari de Bellvitge
Collaborator
