Comparing early left bundle branch pacing with standard therapy for heart failure

Clinical Efficacy of Early Left Bundle Branch Pacing for Cardiac Resynchronization Therapy Compared With Guideline-directed Medical Therapy in Heart Failure With Mild-reduced Ejection Fraction.

This study is testing if a new heart pacing method can help people with heart failure feel better and improve their heart function more than standard medication alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fu Wai Hospital, Beijing, China (Academic / other)
• Locations: 2 sites (Beijing, Beijing and 1 other locations)
• Trial ID: NCT06126081 on ClinicalTrials.gov

What this trial studies

This is a two-center, prospective randomized controlled trial aimed at evaluating the clinical efficacy of early left bundle branch pacing (LBBP) compared to guideline-directed medical therapy (GDMT) in patients with heart failure and mild-reduced ejection fraction. Participants with symptomatic heart failure and complete left bundle branch block will be randomly assigned to receive either LBBP combined with GDMT or GDMT alone. The primary outcome will be the change in left ventricular ejection fraction (LVEF) after six months of treatment. Follow-up assessments will occur at three and six months post-randomization to measure improvements in heart function.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic heart failure, a left ventricular ejection fraction between 36% and 50%, and complete left bundle branch block.

Not a fit: Patients with severe structural heart disease, those requiring immediate cardiac surgery, or those with certain comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved heart function and quality of life for patients with heart failure.

How similar studies have performed: Other studies have explored cardiac resynchronization therapy, but the specific approach of early left bundle branch pacing is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years;
2. symptomatic heart failure despite guideline-directed medical therapy for at least 3 months, NYHA class II-IV, with an EF between 35% and 50%;
3. complete LBBB meeting Strauss's standard definition
4. Signed informed consent.

Exclusion Criteria:

1. Expected survival less than 24 months;
2. Indicated for ICD or pacing therapy;
3. History of VT, VF, or hemodynamic instability;
4. History of mechanical tricuspid valve replacement;
5. Ischemic cardiomyopathy scheduled for CABG and PCI within 3 months;
6. Severe structural heart disease may necessitate cardiac surgery or heart transplantation within 1 year;
7. Pregnancy or planning for pregnancy;
8. Hypertrophic cardiomyopathy or those underwent ventricular septal defect repair, in whom the success of LBBP is anticipated to be challenging;
9. Severe renal dysfunction (eGFR \< 15ml/min\*1.73m\^2).

Where this trial is running

Beijing, Beijing and 1 other locations

• Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)
• The first affiliated hospital of Nanjing medical university — Nanjing, Jiangsu, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Xiaohan Fan, PhD — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Chen He, M.D

Conditions Heart Failure; Left Bundle Branch Pacing; Guideline-Directed Medical Therapy