Accelerated LBBP for Patients With RHF and Severe TR

NCT07470047 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Zhongshan Hospital

Phase

Not applicable

Started

2026-03-10

Last updated

2026-03-13

Condition(s) studied

Right Heart Failure

Investigational drug(s) / intervention(s)

permanent pacemaker implantation

permanent pacemaker implantation: Implant a pacemaker using left bundle branch pacing (LBBP) and set the pacing rate to 90 bpm.

Study summary

This study is a prospective, single-arm, target value clinical trial. We plan to prospectively enroll and follow 24 patients across three centers nationwide who have a low baseline heart rate (HR ≤ 60 bpm), meet the indication for permanent pacemaker implantation, and have right-sided heart failure with severe or greater tricuspid regurgitation. All patients will undergo pacemaker implantation using left bundle branch pacing (LBBP), and the pacing rate will be uniformly increased to 90 bpm (reduced to 80-85 bpm in case of intolerance). Patients will be followed for 6 months to evaluate the effects of heart-rate increase on hemodynamics, heart failure symptoms, and physical function in patients with right-sided heart failure.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Mean resting heart rate ≤ 65 beats/min (based on a resting electrocardiogram). 2. Clinically confirmed right-sided heart failure, requiring ≥2 diuretic units to fully control edema, or having persistent grade ≥1 edema despite diuretic therapy. Diuretic unit definition: expressed as the number of daily doses at the standard oral dose. For example, the standard units for furosemide, torasemide, and spironolactone are 20 mg/day, 10 mg/day, and 20 mg/day, respectively. If a patient takes furosemide 20 mg twice daily and spironolactone 20 mg once daily, the total diuretic units equal 3. 3. Echocardiography shows severe or greater tricuspid regurgitation. 4. With/without an indication for permanent pacemaker implantation. 5. Is able to understand the purpose of the trial, voluntarily participates and signs written informed consent, and is willing to complete follow-up visits as required by the protocol. Exclusion Criteria: 1. Mean pulmonary artery pressure (mPAP) \> 35 mmHg measured by right heart catheterization at a pacing rate of 60 bpm. 2. Left ventricular ejection fraction (LVEF) \< 50% or left ventricular end-diastolic diameter (LVEDD) \> 56 mm as measured by echocardiography. 3. Prior implantation of a cardiac pacemaker. 4. Moderate or greater left-sided valvular regurgitation or stenosis. 5. Current use of heart rate-lowering medications, such as beta-blockers, digoxin, ivabradine, etc. 6. Untreated hypothyroidism. 7. Participation in another drug or medical device clinical trial that has not yet been completed. 8. Deemed unsuitable for participation in this clinical trial by the investigator.

Primary outcome measure(s)

An increase of ≥10 points in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score at the 6-month follow-up compared with baseline. — From enrollment to the 6-month follow-up
Measured as score (score on scale; range 0-100). The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. Lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.

Trial sites (3)

Facility	City	Region
The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
Shanghai Zhongshan Hospital	Shanghai	Shanghai Municipality
Shanghai Geriatric Medical Center	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07470047 on ClinicalTrials.gov ↗ ← All trials in China