Rate-Adaptive Atrial Pacing In Diastolic Heart Failure (RAPID-HF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in Oxygen Consumption (VO2) at Ventilatory Anaerobic Threshold (VAT)
研究概览
简要总结
Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Oxygen Consumption (VO2) at Ventilatory Anaerobic Threshold (VAT)
时间窗: baseline, after 4 weeks of treatment
Maximal effort cardiopulmonary exercise testing was performed on a treadmill after 4 weeks of pacing-on and after 4 weeks of pacing-off to measure volumes of oxygen consumed (VO2). Change in VO2 at anaerobic threshold (VO2,AT) determined by the V-Slope method as the point of disproportionate rise in VCO2 relative to VO2 as measured in ml/kg/min.
次要结局
- Ventilatory Efficiency (VE/VCO2)(4 weeks)
- Peak Aerobic Capacity (Peak VO2)(4 weeks after pacemaker activation)
- Change in Plasma N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)(baseline, after 4 weeks of treatment)
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score(baseline, after 4 weeks of treatment)
研究者
Barry Borlaug
Principal Investigator
Mayo Clinic
