Inspiratory muscle training combined with cardiac rehabilitation for heart failure with reduced ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests whether adding inspiratory muscle training (IMT) using a Powerbreathe device to standard cardiac rehabilitation (CR) changes cardiovascular and exercise responses in people with heart failure with reduced ejection fraction (HFrEF). Participants are adults on guideline-directed medical therapy with NYHA class I–III symptoms who can perform exercise and have no recent hospitalizations. The protocol delivers supervised CR plus a course of IMT and compares exercise and cardiovascular function outcomes to CR without IMT. The single-center study is conducted at Mayo Clinic in Rochester and involves clinical screening and in-person supervised sessions.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Joshua Smith, Ph.D. — Mayo Clinic
• Study coordinator: Eric Bruhn, M.A
• Email: bruhn.eric@mayo.edu
• Phone: 507-266-2690

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• HFrEF polypill strategy in Sri Lanka

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.