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临床试验/NCT02145351
NCT02145351已完成不适用

Rate-Adaptive Atrial Pacing In Diastolic Heart Failure (RAPID-HF)

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2014年4月7日最近更新:
适应症

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

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Barry Borlaug

Principal Investigator

Mayo Clinic

研究点 (2)

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