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Respiratory Muscle Function in Heart Failure

Primary Purpose

Heart Failure, Diastolic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PowerBreathe (Breathing muscle training)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure, Diastolic focused on measuring heart failure preserved ejection fraction, exercise, respiratory muscle

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Breathing muscle training

Sham breathing muscle training

Arm 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.

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.

Outcomes

Primary Outcome Measures

Breathing muscle oxygen cost
Breathing muscle oxygen uptake between heart failure and healthy participants
Respiratory muscle blood flow
Breathing muscle blood flow between heart failure and healthy participants
Systolic and diastolic blood pressure
Respiratory muscle workout-induced increases in systolic and diastolic blood pressure between heart failure and healthy participants
Breathing muscle oxygen cost
Breathing muscle oxygen uptake from pre to post-breathing muscle training in heart failure participants
Respiratory muscle blood flow
Breathing muscle blood flow rom pre to post-breathing muscle training in heart failure participants
Systolic and diastolic blood pressure
Respiratory muscle workout-induced increases in systolic and diastolic blood pressure from pre to post-breathing muscle training in heart failure participants

Secondary Outcome Measures

Full Information

First Posted
February 4, 2019
Last Updated
January 9, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03924479
Brief Title
Respiratory Muscle Function in Heart Failure
Official Title
Respiratory Muscle-mediated Neural and Cardiovascular Consequences in Heart Failure With Preserved Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diastolic
Keywords
heart failure preserved ejection fraction, exercise, respiratory muscle

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breathing muscle training
Arm Type
Experimental
Arm 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 Title
Sham breathing muscle training
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
PowerBreathe (Breathing muscle training)
Other Intervention Name(s)
PowerBreathe Device
Intervention 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.
Primary Outcome Measure Information:
Title
Breathing muscle oxygen cost
Description
Breathing muscle oxygen uptake between heart failure and healthy participants
Time Frame
Year 1
Title
Respiratory muscle blood flow
Description
Breathing muscle blood flow between heart failure and healthy participants
Time Frame
Year 1
Title
Systolic and diastolic blood pressure
Description
Respiratory muscle workout-induced increases in systolic and diastolic blood pressure between heart failure and healthy participants
Time Frame
Year 1
Title
Breathing muscle oxygen cost
Description
Breathing muscle oxygen uptake from pre to post-breathing muscle training in heart failure participants
Time Frame
Year 2
Title
Respiratory muscle blood flow
Description
Breathing muscle blood flow rom pre to post-breathing muscle training in heart failure participants
Time Frame
Year 2
Title
Systolic and diastolic blood pressure
Description
Respiratory muscle workout-induced increases in systolic and diastolic blood pressure from pre to post-breathing muscle training in heart failure participants
Time Frame
Year 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas P Olson
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Bruhn
Phone
507-266-2690
Email
bruhn.eric@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Respiratory Muscle Function in Heart Failure

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