Clinical Efficacy of Early Left Bundle Branch Pacing for Cardiac Resynchronization Therapy

Heart Failure Clinical Trial

— Early-RESYNC  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06126081
• Other study ID #: 2023-1996
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: November 2023
• Source: Fu Wai Hospital, Beijing, China
• Contact: Chen He, M.D
• Phone: +8618059707043
• Email: 18059707043[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a two-center, prospective randomized controlled trial. The aim of this study is to compare the clinical efficacy of early left bundle branch pacing for cardiac resynchronization therapy and guideline-directed medical therapy in heart failure with mild-reduced ejection fraction.

Description:

Early-resync is a two-center, prospective randomized controlled trial that is designed to determine whether early left bundle branch pacing has a better impact on LV function improvement as compared with traditional guideline-directed medical therapy in heart failure with mild-reduced ejection fraction（36%≤LVEF≤50%） and complete left bundle branch block (CLBBB). Patients with symptomatic heart failure,36%≤LVEF≤50%, NYHA function class II-IV, and CLBBB（according to STRAUSS criteria) will be 1:1 randomized to LBBP+GDMT or GDMT group after enrollment and be followed at 3 and 6 months after randomization. LBBP will be performed by a double-chamber device in LBBP+GDMT group. All patients will receive GDMT. The primary endpoint is the change in the LVEF at 6 months after randomization from baseline.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• LBBP+GDMT
LBBP is a procedure that the pacing lead is placed at the left bundle branch to achieve electrical and mechanical synchronization by pacing the left bundle branch area with stable pacing parameters.

Drug:
• GDMT
GDMT is defined as the drug strategy for treatment of heart failure according to the current guidelines.

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences	Beijing	Beijing
China	The first affiliated hospital of Nanjing medical university	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Fu Wai Hospital, Beijing, China	The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?LVEF between baseline and 6-month follow-up	?LVEF:change in LVEF in percentage (%) between baseline and 6-month follow-up	6 months
Secondary	?LVEDD and ?LVESV between baseline and 6-month follow-up	?LVEDD:change in LVEDD in millimeters between baseline and 6-month follow-up between two groups.; ?LVESV:change in LVESV in milliliters between baseline and 6-month follow-up between two groups.	6 months
Secondary	The echocardiographic response rate of LVEF =50%	the percentage of patients with LVEF =50% at 6 month follow-up	6 months
Secondary	The changes of NYHA function class between baseline and 6-month follow-up.	NYHA function class (from I to IV) is evaluated by clinicians at each outpatient follow-up visit;	6 months
Secondary	Composite incidence rate of all-cause mortality and/or hospitalization for heart failure	All-cause death: including cardiovascular and non-cardiovascular deaths. Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy.	6 months
Secondary	The rate of LVEF <=35% at six-month	The percentage of patients with LVEF <=35% at 6 month follow-up	6 months
Secondary	The changes of NT-proBNP between baseline and 6-month follow-up.	NT-proBNP in pg/ml was measured by performing a blood test;	6 months
Secondary	The changes of 6MWD between baseline and 6-month follow-up.	6MWD in meters stands for "6-Minute Walk Distance." It is a common test used to assess a person's functional exercise capacity and cardiovascular endurance. During the test, the patient is asked to walk as far as possible within a span of 6 minutes in a straight path or designated walking course;	6 months
Secondary	The changes of QoL between baseline and 6-month follow-up.	QoL stands for "Quality of Life", which is measured by The Minnesota Living with Heart Failure Questionnaire (MLHFQ). The MLHFQ is a self-administered disease-specific questionnaire for patients with HF, comprising 21 items from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL).	6 months