Comparison of left bundle branch pacing and biventricular pacing in the treatment of chronic systolic heart failure with left bundle branch block: a multicenter, prospective, randomized, controlled trial

Not Applicable

Recruiting

• Conditions: Heart failure

• Registration Number: ChiCTR2000036554
• Lead Sponsor: Zhongshan Hospital, Fudan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age 18 to 80 years;<br>2. Sinus rhythm, complete LBBB meeting Strauss’s standard definition;<br>3. Left ventricular ejection Fraction <= 35% with New York Heart Association (NYHA) functional class II to IV despite receiving at least 3 months’ guideline directed medical therapy;<br>4. Expected survival time > 1 year;<br>5. The residence is stable and can meet the requirements of follow-up during the study period.

Exclusion Criteria

1. decline to participate or refuse to sign the written informed consent;<br>2. pregnant or planning to become pregnant;<br>3. participate in other clinical studies;<br>4. patients with mechanical tricuspid valve implantation;<br>5. persistent or permanent atrial fibrillation;<br>6. heart transplant patients or patients waiting for heart transplantation;<br>7. Patients with severe renal dysfunction of blood creatinine>2.5mg/dl or>275umol/L or glomerular filtration rate <= 30 ml/min/1.72m^2 within 30 days prior to enrollment;<br>(9) Patients with severe liver dysfunction of liver function exceeding three times the upper limit of normal values in the five liver function items within 30 days before enrollment.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite outcome of all-cause mortality and heart failure hospitalization;

Secondary Outcome Measures

Name	Time	Method
Outcome of all-cause mortality;Outcome of heart failure hospitalization;Echocardiographic response/super-response rate;