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

Respiratory Muscle Function in Heart Failure

Sponsors

Lead sponsor: Mayo Clinic

Source Mayo Clinic
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.

Overall Status Recruiting
Start Date November 28, 2018
Completion Date December 2021
Primary Completion Date December 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Breathing muscle oxygen cost Year 1
Respiratory muscle blood flow Year 1
Systolic and diastolic blood pressure Year 1
Breathing muscle oxygen cost Year 2
Respiratory muscle blood flow Year 2
Systolic and diastolic blood pressure Year 2
Enrollment 30
Condition
Intervention

Intervention type: Device

Intervention name: PowerBreathe (Breathing muscle training)

Description: 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 name: PowerBreathe Device

Eligibility

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).

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

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Thomas P Olson Principal Investigator Mayo Clinic
Location
facility status contact Mayo Clinic in Rochester Eric Bruhn 507-266-2690 [email protected]
Location Countries

United States

Verification Date

May 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Mayo Clinic

Investigator full name: Thomas P. Olson, M.S., Ph.D.

Investigator title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Breathing muscle training

Arm group type: Experimental

Description: 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.

Arm group label: Sham breathing muscle training

Arm group type: Sham Comparator

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: Single (Participant)

Source: ClinicalTrials.gov