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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

1. Non-ischemic cardiomyopathy with LVEF≤35% as assessed by echocardiography, NYHA class II-III, and less than 3 months of optimized (complete) GDMT*;

2. Sinus rhythm (paroxysmal atrial fibrillation may be present) with complete left bundle branch block meeting STRAUSS's criteria;

3. Between the ages of 18 and 80;

4. With informed consent signed.

Exclusion Criteria:

1. After mechanical tricuspid valve replacement;

2. Ischemic cardiomyopathy;

3. Persistent AF without AV node ablation;

4. History of unexplained syncope or indications for pacemaker implantation;

5. Indications for ICD implantation such as a history of sustained ventricular tachycardia or sudden cardiac arrest;

6. Unstable angina, acute MI, CABG or PCI within the past 3 months;

7. Enrollment in any other study；

8. A life expectancy of less than 12 months;

9. Pregnant or with child-bearing potential;

10. History of heart transplantation.