Respiratory Muscle Function in Heart Failure

  • STATUS
    Recruiting
  • End date
    Dec 25, 2022
  • participants needed
    30
  • sponsor
    Mayo Clinic
Updated on 25 March 2022
Accepts healthy volunteers

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.

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.

Details
Condition Heart Failure, Diastolic
Treatment PowerBreathe (Breathing muscle training)
Clinical Study IdentifierNCT03924479
SponsorMayo Clinic
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinical diagnosis of HFpEF
Patients with a history stable (no medication changes in past 6 weeks (w/duration of
New York Heart Association class I-III
diagnosis >6 months)
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

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
diagnosis of liver disease
individuals who are not able to engage in exercise
creatinine value greater than or equal to 1.3 mg/dL (via clinical record within the
past 6 months)
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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