Bachmann Bundle Area Pacing for Atrial Resynchronization Therapy in Patients With HFpEF: A Randomized Trail (BART-HFpEF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Relative Change in N-proBNP compared with baseline
研究概览
简要总结
Bachmann Bundle Area Pacing for Atrial Resynchronization Therapy in Patients with HFpEF A Randomized Trial BART HFpEF. To assess the effect of atrial resynchronization using Bachmann Bundle Area Pacing in symptomatic patients with Heart Failure with Preserved Ejection Fraction HFpEF and interatrial block IAB. This multi-center prospective randomized controlled trial will include symptomatic patients over 18 years with stage C HFpEF. Key inclusion criteria include NT proBNP level greater than 300 pg per ml and NYHA Class 2 or higher. All participants will receive a dual chamber pacemaker. Patients will be randomized to either Bachmann Bundle Area or the Right Atrial Appendage atrial lead implantation. Pacing will be set at DDDR mode 70 beats per minute for 6 weeks followed by a 6-week washout. During the washout period the device will be programmed to VVI at 30 beats per minute. After six weeks of washout, device will be programmed to DDDR at 70 per minute. Primary endpoint is Change in NT proBNP levels from baseline. Secondary Endpoints include relative change in diastolic function on echocardiography, six minute walk distance, NYHA class, Heart failure hospitalizations, Atrial arrhythmia burden, Daily diuretic requirement, Kansas City Cardiomyopathy Questionnaire score. The sample size required to detect a 50 pg per ml change in NT proBNP with 90 percent power and 5 percent significance will be a 124 patients. Enrollment will be more 18 months, with a minimum follow up of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Symptomatic patients more than 18 years with Stage C HFpEF (LVEF greater than 50%) and chronotropic incompetence on optimized guideline indicated HF medical therapy -NYHA more than Class 2 and an elevated N-terminal pro-B type natriuretic peptide (NT-proBNP) level higher than 300 pg/ml -Partial or complete inter-atrial block (IAB) on ECG.
- •IAB will be defined as a maximum P wave duration greater than 120ms.
- •Partial IAB will be defined as a P wave greater than 120ms with notching in leads II, III, or aVF.
- •A P wave duration greater than 120ms and a biphasic morphology in leads II, III, aVF will be classified as advanced or complete IAB.
- •Baseline PR interval less than 200ms -Baseline HR less than 60/min or an average heart rate on baseline holter that is less than 65/min.
排除标准
- •Persistent atrial fibrillation -History of corrected or uncorrected congenital heart disease -Severe mitral valve disease -Previous mitral surgery.
- •Indication for Ventricular pacing -Pregnancy -Stage IV/V Chronic Kidney Disease -Multiple comorbidities with an estimated life expectancy more than 1 year -Patients unable to give written or informed consent.
结局指标
主要结局
Relative Change in N-proBNP compared with baseline
时间窗: 4 weeks 8 weeks 12 weeks and 24 weeks (derived from the study duration of 24 months with key intervals likely aligned with the washout period and follow-up phases)
次要结局
- 1) Diastolic function assessment by echocardiography(2) HF Hospitalizations)
研究者
Dr Calambur Narasimham
Asian Institute Of Gastroenterology