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Recruiting
NCT07851779
Withdrawal of Heart Failure Treatment Patients With Non-ischemic Cardiomyopathy Who Have Been Super-responders to Cardiac Resynchronization Therapy.
Conditions: Non-ischemic Cardiomyopathy, Cardiac Resynchronisation Therapy (CRT)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 64
Sponsor: Institut d'Investigació Biomèdica de Bellvitge
Location: Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona
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.
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 \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 \
Source: ClinicalTrials.gov (NCT07851779). StuddyBuddy aggregates publicly available trial information.