LBBP as Initial Therapy in Patients With Non-ischemic Heart Failure and LBBB
Status:
Not yet recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
The present study will recruit 50 symptomatic non-ischemic cardiomyopathy (NICM) patients
with left ventricular ejection fraction (LVEF) below 35% and complete left bundle branch
block (CLBBB), who have not received complete guideline-directed medical therapy (GDMT). Each
patient was randomized to 2 groups, GDMT or left bundle branch pacing combined with GDMT
(LBBP+GDMT) as initial therapy and was followed up for 2 phases: 0-6 months (phase I), 7-18
months (phase II). The primary objective is to compare the LVEF change , syncope and
malignant ventricular arrhythmias between GDMT group and LBBP+GDMT group, and to observe
which strategy will significantly reduce the percentage of recommendations for an implantable
cardioverter-defibrillator (ICD) during phase I study. The second outcome measures including
health economics, echocardiography parameters[left ventricular ejection fraction (LVEF), left
ventricular end-systolic volume (LVESV), left ventricular end-diastolic volume (LVEDV)],
N-terminal pro B-type natriuretic peptide (NT-proBNP) level, New York Heart Association
(NYHA) class, 6-minute walking distance (6MWD), quality of life score(QOL) and incidence of
clinical adverse events.
Phase:
N/A
Details
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborators:
Chinese Academy of Medical Sciences, Fuwai Hospital First Affiliated Hospital of Wenzhou Medical University Fujian Medical University Union Hospital The First Affiliated Hospital of Dalian Medical University West China Hospital