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PowerBreathe for Heart Failure

N/A

Waitlist Available

Led By Thomas P Olson

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Clinical diagnosis of HFpEF.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 2

Awards & highlights

Study Summary

This trial is investigating if improving respiratory muscle function can help people with heart failure exercise better.

Eligible Conditions

Diastolic Heart Failure

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Healthy adults over 21 years old without a history of certain heart, lung, nerve, or bone conditions. The participants will be similar in age and gender.

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You have been diagnosed with heart failure with preserved ejection fraction (HFpEF).

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You have been diagnosed with New York Heart Association classes I to III.

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You have smoked less than a pack of cigarettes a day for 15 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Breathing muscle oxygen cost

Respiratory muscle blood flow

Diastolic blood pressure

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Breathing muscle trainingExperimental Treatment1 Intervention

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.

Group II: Sham breathing muscle trainingPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PowerBreathe (Breathing muscle training)

2018

N/A

~30

0 / 4Eligibility criteria met