Respiratory Muscle Function in Heart Failure

March 21, 2024 updated by: Thomas P. Olson, M.S., Ph.D., Mayo Clinic

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

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.

Study Overview

Status

Completed

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
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
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breathing muscle oxygen cost
Time Frame: Year 1
Breathing muscle oxygen uptake between heart failure and healthy participants
Year 1
Respiratory muscle blood flow
Time Frame: Year 1
Breathing muscle blood flow between heart failure and healthy participants
Year 1
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
Year 1
Breathing muscle oxygen cost
Time Frame: Year 2
Breathing muscle oxygen uptake from pre to post-breathing muscle training in heart failure participants
Year 2
Respiratory muscle blood flow
Time Frame: Year 2
Breathing muscle blood flow rom pre to post-breathing muscle training in heart failure participants
Year 2
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
Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Thomas P Olson, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2018

Primary Completion (Actual)

March 21, 2024

Study Completion (Actual)

March 21, 2024

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

April 22, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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