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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- ΔLVEF between baseline and 6-month follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •symptomatic heart failure despite guideline-directed medical therapy for at least 3 months, NYHA class II-IV, with an EF between 35% and 50%;
- •complete LBBB meeting Strauss's standard definition
- •Signed informed consent.
排除标准
- •Expected survival less than 24 months;
- •Indicated for ICD or pacing therapy;
- •History of VT, VF, or hemodynamic instability;
- •History of mechanical tricuspid valve replacement;
- •Ischemic cardiomyopathy scheduled for CABG and PCI within 3 months;
- •Severe structural heart disease may necessitate cardiac surgery or heart transplantation within 1 year;
- •Pregnancy or planning for pregnancy;
- •Hypertrophic cardiomyopathy or those underwent ventricular septal defect repair, in whom the success of LBBP is anticipated to be challenging;
- •Severe renal dysfunction (eGFR < 15ml/min*1.73m^2).
研究组 & 干预措施
LBBP+GDMT group
Patients in the LBBP+GDMT group will receive LBBP using dual-chamber device as priority and guideline-directed medical therapy. The pacing lead will be implanted at the left bundle branch and whether LBB is captured will be judged during the procedure. For patients who LBBP is failed, CRTP using triple-chamber device or LVSP by using dual-chamber device will be an alternative option according to the co-determination after consultation between doctors and patients .
干预措施: LBBP+GDMT (Device)
GDMT group
Patients in the GDMT group will receive guideline-directed medical therapy according to their complications, heart rate, blood pressure and so on. During follow-up of 6 months, patients may transfer to LBBP group if the LVEF decreased to <35% and patients accepted the device implantation.
干预措施: GDMT (Drug)
结局指标
主要结局
ΔLVEF between baseline and 6-month follow-up
时间窗: 6 months
ΔLVEF：change in LVEF in percentage (%) between baseline and 6-month follow-up
次要结局
- The rate of LVEF <=35% at six-month(6 months)
- The echocardiographic response rate of LVEF ≥50%(6 months)
- Composite incidence rate of all-cause mortality and/or hospitalization for heart failure(6 months)
- The changes of 6MWD between baseline and 6-month follow-up.(6 months)
- ΔLVEDD and ΔLVESV between baseline and 6-month follow-up(6 months)
- The changes of NT-proBNP between baseline and 6-month follow-up.(6 months)
- The changes of NYHA function class between baseline and 6-month follow-up.(6 months)
- The changes of QoL between baseline and 6-month follow-up.(6 months)
研究者
Xiaohan Fan
Professor, MD, PhD
Fu Wai Hospital, Beijing, China