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Completed

NCT Number: NCT03924479

Respiratory Muscle Function in Heart Failure

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PowerBreathe (Breathing muscle training)

Device

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: PowerBreathe Device

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Apr 23, 2019
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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