- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03924479
Respiratory Muscle Function in Heart Failure
Respiratory Muscle-mediated Neural and Cardiovascular Consequences in Heart Failure With Preserved Ejection Fraction
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Healthy subjects: Adults (≥21 years of age) in the absence of a history of HFpEF or HFrEF, pulmonary, neurologic, orthopedic, or other diseases affecting the neuromuscular system. Controls will be matched for age and sex.
All HFpEF patients will be managed by their primary care physician or cardiologist with additional review and oversight by Dr. Borlaug (Co-Investigator) prior to enrollment to ensure adequacy of inclusion and exclusion criteria and that participation in exercise testing and resistance exercise training is safe.
Inclusion Criteria for HFpEF, includes:
- Clinical diagnosis of HFpEF.
- Patients with a history stable (no medication changes in past 6 weeks (w/duration of diagnosis >6 months).
- New York Heart Association class I-III.
- Current non-smokers with <15 pack year history.
- Non-pregnant women, and individuals who are able to exercise (i.e. without orthopedic limitations or neuromuscular disorders).
Exclusion Criteria for all subjects, includes:
- history of dangerous arrhythmias
- body mass index >35 kg/m2
- current smokers and/or smoking history >15 pack years
- pregnant women
- uremia, history of allergy to iodides
- impaired renal function
- creatinine value greater than or equal to 1.3 mg/dL (via clinical record within the past 6 months)
- diagnosis of liver disease
- individuals who are not able to engage in exercise
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breathing muscle training
The breathing muscle training will consist of 7 sessions per week (1 per day) for 8 weeks.
Each training session will consist of breathing ~15 times each minute for 30 minutes at 40% of maximal breathing muscle strength, while using the breathing muscle trainer.
During the inhalation, participants will be instructed to inhale as fast as they can, while exhalations will be performed at the participants discretion.
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The breathing muscle breathing training will consist of using the PowerBreathe training for 8 weeks.
The PowerBreathe is an inspiratory pressure threshold trainer.The valve blocks the airflow until the threshold pressure is achieved by breathing in forcefully into the device.
Other Names:
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Sham Comparator: Sham breathing muscle training
The breathing muscle training will consist of 7 sessions per week (1 per day) for 8 weeks.
Each training session will consist of breathing ~15 times each minute for 30 minutes at 2%% of maximal breathing muscle strength, while using the breathing muscle trainer.
During the inhalation, participants will be instructed to inhale as fast as they can, while exhalations will be performed at the participants discretion.
|
The breathing muscle breathing training will consist of using the PowerBreathe training for 8 weeks.
The PowerBreathe is an inspiratory pressure threshold trainer.The valve blocks the airflow until the threshold pressure is achieved by breathing in forcefully into the device.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breathing muscle oxygen cost
Time Frame: Year 1
|
Breathing muscle oxygen uptake between heart failure and healthy participants
|
Year 1
|
Respiratory muscle blood flow
Time Frame: Year 1
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Breathing muscle blood flow between heart failure and healthy participants
|
Year 1
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Systolic and diastolic blood pressure
Time Frame: Year 1
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Respiratory muscle workout-induced increases in systolic and diastolic blood pressure between heart failure and healthy participants
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Year 1
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Breathing muscle oxygen cost
Time Frame: Year 2
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Breathing muscle oxygen uptake from pre to post-breathing muscle training in heart failure participants
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Year 2
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Respiratory muscle blood flow
Time Frame: Year 2
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Breathing muscle blood flow rom pre to post-breathing muscle training in heart failure participants
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Year 2
|
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
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Year 2
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas P Olson, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-007785
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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