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Clinical Trials/NCT03924479
NCT03924479
Completed
N/A

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

Mayo Clinic1 site in 1 country30 target enrollmentNovember 28, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure, Diastolic
Sponsor
Mayo Clinic
Enrollment
30
Locations
1
Primary Endpoint
Breathing muscle oxygen cost
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 28, 2018
End Date
March 21, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Breathing muscle oxygen cost

Time Frame: Year 2

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

Systolic and diastolic blood pressure

Time Frame: 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

Time Frame: Year 2

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

Study Sites (1)

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