Recruiting

IMT & CR

Sponsor:

Mayo Clinic

Code:

NCT07086131

Conditions

Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Powerbreathe

Study Details

Brief summary:

The purpose of this study is to compare the impact of inspiratory muscle training (IMT) combined with cardiac rehabilitation (CR) on cardiovascular function in patients with heart failure.

Conditions

Heart Failure With Reduced Ejection Fraction

Study ID

NCT07086131

Start date

Sep 4, 2025

Status verified date

Jul, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Inspiratory muscle training (IMT)

IMT performed at 40% maximal inspiratory pressure (MIP) for 30 minutes 3 days a week for 12 weeks.

sham comparator: SHAM

IMT performed at 5% maximal inspiratory pressure (MIP) for 30 minutes 3 days a week for 12 weeks.

Interventions

Powerbreathe

The breathing training will consist of using the PowerBreathe for 12 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

  • Change in locomotor muscle blood flow during exercise [ Time Frame: Baseline, 12 weeks ]
  • Change in respiratory muscle cost of breathing (VO2) [ Time Frame: Baseline, 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Joshua R Smith

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 7, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-07.