Withdrawal of Heart failure medications: Heart failure drugs will be withdrawn progressively over a maximum of 9 weeks, discontinuing drugs one by one following a predefined sequence
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Recurrence of left ventricular dysfunction or heart failure symptoms at 6 months — 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.
Trial sites (4)
Facility
City
Region
Status
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat
Barcelona
Recruiting
Hospital Vall d'Hebron
Barcelona
Spain
Recruiting
Hospital Trueta
Girona
Spain
Recruiting
Hospital Virgen de las Nieves
Granada
Spain
Recruiting
More Institut d'Investigació Biomèdica de Bellvitge trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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