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临床试验/NCT03924479
NCT03924479已完成不适用

Respiratory Muscle-mediated Neural and Cardiovascular Consequences in Heart Failure With Preserved Ejection Fraction

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年11月28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
30
试验地点
2
主要终点
Breathing muscle oxygen cost

研究概览

简要总结

This study is being done because investigators are trying to determine how respiratory muscle and lung function influence the exercise responses in heart failure and healthy participants. Further, the heart failure patients will participate in an intervention to improve their respiratory muscle function to determine if this improves exercise capacity.

详细描述

The participants enrolled in this study will be asked to make 4 or 9 separate study visits. Healthy participants will perform 4 study visits and heart failure participants will perform 9 study visits.

During study visit 1, the participants will be asked to get a DEXA bone scan, perform pulmonary function tests, and exercise on a stationary bike at maximal exertion while breathing into a mouth piece. During the exercise test, a iodine-based dye will be injected via a venous catheter in the arm. Also, a thin balloon will be inserted through the nose into the esophagus.

During study visit 2, the participants will breathe the same way they did during exercise, but will be seated and not exercising. A thin balloon will be inserted through the nose into the esophagus.

During study visits 3 and 4, the participants will perform different respiratory muscle workouts at rest that will be at different intensities ranging from very easy to moderate for ~10 minutes. An iodine-based dye will be injected via a venous catheter in the arm.

The participant's with heart failure will then perform 8 weeks of breathing muscle training at home. After 3 weeks of breathing muscle training, the participants will return for study visit 5 where the training load will be adjusted. Following the 8 weeks of breathing muscle training, the heart failure participants will perform the same 4 study visits as outlined above.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
21 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

Breathing muscle oxygen cost

时间窗: Year 2

Breathing muscle oxygen uptake from pre to post-breathing muscle training in heart failure participants

Systolic and diastolic blood pressure

时间窗: Year 2

Respiratory muscle workout-induced increases in systolic and diastolic blood pressure from pre to post-breathing muscle training in heart failure participants

Respiratory muscle blood flow

时间窗: Year 2

Breathing muscle blood flow rom pre to post-breathing muscle training in heart failure participants

次要结局

未报告次要终点

研究者

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

Thomas P. Olson, M.S., Ph.D.

Principal Investigator

Mayo Clinic

研究点 (2)

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