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Respiratory Muscle Function in Heart Failure

  • Clinicaltrials.gov identifier

    NCT03924479

  • Recruitment Status

    Recruiting

  • First Posted

    April 23, 2019

  • Last update posted

    June 16, 2021

Study Description

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.

  • Condition or Disease:Heart Failure, Diastolic
  • Intervention/Treatment: Device: PowerBreathe (Breathing muscle training)
  • Phase: N/A

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 Design

  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Other
  • Official Title: Respiratory Muscle-mediated Neural and Cardiovascular Consequences in Heart Failure With Preserved Ejection Fraction
  • Actual Study Start Date: November 2018
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021

Arms and interventions

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.
Device: PowerBreathe (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.
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.
Device: PowerBreathe (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.

Outcome Measures

  • Primary Outcome Measures: 1. Breathing muscle oxygen cost [ Time Frame: Year 1 ]
    Breathing muscle oxygen uptake between heart failure and healthy participants
  • 2. Respiratory muscle blood flow [ Time Frame: Year 1 ]
    Breathing muscle blood flow between heart failure and healthy participants
  • 3. Systolic and diastolic blood pressure [ Time Frame: Year 1 ]
    Respiratory muscle workout-induced increases in systolic and diastolic blood pressure between heart failure and healthy participants
  • 4. Breathing muscle oxygen cost [ Time Frame: Year 2 ]
    Breathing muscle oxygen uptake from pre to post-breathing muscle training in heart failure participants
  • 5. Respiratory muscle blood flow [ Time Frame: Year 2 ]
    Breathing muscle blood flow rom pre to post-breathing muscle training in heart failure participants
  • 6. 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

Eligibility Criteria

  • Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes

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 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

Contacts and Locations

Contacts

Locations

United States, Minnesota
Mayo Clinic in Rochester
Rochester

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Thomas P Olson Mayo Clinic

More Information

  • Responsible Party: Mayo Clinic
  • ClinicalTrials.gov Identifier: NCT03924479 History of Changes
  • Other Study ID Numbers: 17-007785
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: June 16, 2021
  • Last Verified: June 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Mayo Clinic: heart failure preserved ejection fraction
    exercise
    respiratory muscle
  • Additional relevant MeSH terms: Heart Failure Heart Failure, Diastolic