Heart Failure, Diastolic
Conditions
Keywords
heart failure preserved ejection fraction, exercise, respiratory muscle
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.
Interventions
DEVICEPowerBreathe (Breathing muscle training)
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breathing muscle oxygen cost | Year 1 | Breathing muscle oxygen uptake between heart failure and healthy participants |
| Respiratory muscle blood flow | Year 1 | Breathing muscle blood flow between heart failure and healthy participants |
| Systolic and diastolic blood pressure | Year 1 | Respiratory muscle workout-induced increases in systolic and diastolic blood pressure between heart failure and healthy participants |
Countries
United States
Outcome results
None listed