NCT04157660已完成不适用
Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity (CPET) in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Work Rate (Watt)
研究概览
简要总结
In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with heart failure with preserved ejection fraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HFpEF, stable medication for at least 4 weeks.
排除标准
- •instable status, pregnancy, clinically relevant concomitant diseases, inability to follow the study procedures
研究组 & 干预措施
Supplemental oxygen
Experimental
Supplemental oxygen will be applied via a mask during CPET
干预措施: Oxygen application (Procedure)
Sham room air
Sham Comparator
Room air will be applied similarly to oxygen
干预措施: Sham room air (Procedure)
结局指标
主要结局
Work Rate (Watt)
时间窗: 1 day
Maximal Work Rate (Watt max) measured during cardiopulmonary exercise test oxygen vs. room air
Endurance Time (s)
时间窗: 1 day
Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air
次要结局
- Respiratory Exchange Ratio (RER)(1 day)
- Changes in arterial blood parameters (pH)(1 day)
- Changes in arterial blood parameters (PaO2)(1 day)
- Changes in arterial blood parameters (PaCO2)(1 day)
- Peak Oxygen uptake (VO2 max)(1 day)
- Changes in arterial blood parameters (Lactat)(1 day)
- muscle tissue oxygen(1 day)
- cerebral tissue oxygen(1 day)
- Changes in arterial blood parameters (Bicarbonate)(1 day)
研究者
研究点 (1)
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