Using left bundle branch pacing for heart failure treatment

Left Bundle Branch Pacing as Initial Therapy in Patients With Non-ischemic Heart Failure and Left Bundle Branch Block (LIT-HF Study)

This study is testing if adding a special heart pacing technique to standard treatment can help people with heart failure feel better and improve their heart function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Locations: 6 sites (Beijing, Beijing Municipality and 5 other locations)
• Trial ID: NCT05572957 on ClinicalTrials.gov

What this trial studies

This study aims to recruit 50 patients with symptomatic non-ischemic cardiomyopathy and left bundle branch block, who have not yet received complete guideline-directed medical therapy. Participants will be randomized into two groups: one receiving standard medical therapy and the other receiving left bundle branch pacing combined with medical therapy. The study will follow patients over two phases, assessing changes in left ventricular ejection fraction, syncope, and ventricular arrhythmias. The goal is to determine which treatment strategy is more effective in improving heart function and reducing the need for implantable cardioverter-defibrillators.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with non-ischemic cardiomyopathy and left ventricular ejection fraction below 35%.

Not a fit: Patients with ischemic cardiomyopathy or those who have indications for immediate pacemaker or ICD implantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve heart function and reduce complications in patients with heart failure.

How similar studies have performed: While traditional pacing methods have been established, the use of left bundle branch pacing is a newer approach and its effectiveness is still being evaluated.

Eligibility 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.

Where this trial is running

Beijing, Beijing Municipality and 5 other locations

• Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Not_yet_recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Jiangang Zou, MD,Ph.D — First Affiliated Hospital, Nanjing Medical University
• Study coordinator: Jiangang Zou, MD,Ph.D

Conditions Non-ischemic Cardiomyopathy; Heart Failure; Left Bundle-Branch Block; Guideline-Directed Medical Therapy; Left Bundle Branch Pacing; Implantable Cardioverter-Defibrillator; Cardiac Resynchronization Therapy