Clinical trial NCT06126081: Clinical Efficacy of Early Left Bundle Branch Pacing for Cardiac Resynchronization Therapy
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Left Bundle Branch Pacing
Keywords: Heart Failure
Left Bundle Branch Pacing
Guideline-Directed Medical Therapy
Lead sponsor: Fu Wai Hospital, Beijing, China
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
First posted: 2023-11-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomized to two groups
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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).

Primary outcomes:
measure: ΔLVEF between baseline and 6-month follow-up
timeFrame: 6 months
Secondary outcomes:
measure: ΔLVEDD and ΔLVESV between baseline and 6-month follow-up
timeFrame: 6 months
measure: The echocardiographic response rate of LVEF ≥50%
timeFrame: 6 months
measure: The changes of NYHA function class between baseline and 6-month follow-up.
timeFrame: 6 months
measure: Composite incidence rate of all-cause mortality and/or hospitalization for heart failure
timeFrame: 6 months
measure: The rate of LVEF <=35% at six-month
timeFrame: 6 months
measure: The changes of NT-proBNP between baseline and 6-month follow-up.
timeFrame: 6 months
measure: The changes of 6MWD between baseline and 6-month follow-up.
timeFrame: 6 months
measure: The changes of QoL between baseline and 6-month follow-up.
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
state: Beijing
city: Nanjing
country: China
facility: The first affiliated hospital of Nanjing medical university
state: Jiangsu
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xiaohan Fan, PhD
role: PRINCIPAL_INVESTIGATOR
References: