Simple breathing device could help heart failure patients exercise better
NCT ID NCT07086131
First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study tests whether adding inspiratory muscle training (using a device called PowerBreathe) to standard cardiac rehabilitation can improve how well the heart and muscles work during exercise in people with heart failure. Researchers will measure blood flow and oxygen use in 70 participants over 12 weeks. The goal is to see if this extra training makes exercise easier and more effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PowerBreathe device
- What this could lead to
- If it works, this could point toward a simple, low-cost way to improve exercise capacity and quality of life for people with heart failure.
- What could go wrong
- This is a small, early-stage study (70 people) looking at short-term changes in blood flow and oxygen use, not long-term outcomes. The breathing device may not provide added benefit over standard cardiac rehab alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria HFrEF Patients: (≥18 yrs) receiving guideline directed pharmacologic medical therapy for \>6 weeks (those with contraindications to medical therapy will meet inclusion criteria), NYHA symptoms I-III, no hospitalizations in the \>3 months, have a body mass index ≤45 kg/m2, currently be non-smokers with \<30 pack year history and be able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise). Exclusion Criteria 1. sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1; 2. second or third degree heart block; 3. body mass index \>45 kg/m2; 4. current smokers and/or smoking history \>30 pack years; 5. pregnant women (testing will be done by research team if requested); 6. glomerular filtration rate of \<30 mL/min/1.73m2 (initial screen via clinical record within the past 6 months and this will be assessed on Visit 1); 7. individuals who are not able to engage in exercise; 8. symptomatic peripheral artery disease; 9. asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea; 10. ruptured eardrum or any other condition of the ear; 11. history of spontaneous pneumothorax or osteoporosis with a history of rib fractures; 12. history of lung disease. For individuals agreeing to undergo dual energy x-ray absorptiometry (DEXA) scanning for measurement of body composition as part of their study visit, additional exclusion criteria apply: recently administered gastrointestinal contrast or radionuclides; severe degenerative changes or fracture deformity in measurement areas; or inability to attain correct position and/or remain motionless for the measurement period.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
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