Inspiratory muscle training for heart failure patients
Inspiratory Muscle Training in Heart Failure With Preserved Ejection Fraction
This study tests if a special breathing exercise program can help heart failure patients breathe better and improve their ability to exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06510231 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of inspiratory muscle training on the function of inspiratory muscles during exercise in patients with heart failure. Participants will undergo a structured training program aimed at improving their respiratory muscle strength and overall exercise capacity. The study focuses on patients who have been on specific heart failure medications for at least three months and are able to engage in physical activity. The goal is to assess whether this training can enhance their quality of life and exercise performance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with heart failure symptoms classified as NYHA I-III who are on specific heart failure medications.
Not a fit: Patients with severe heart conditions, significant orthopedic limitations, or those unable to engage in exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve exercise capacity and quality of life for heart failure patients.
How similar studies have performed: Previous studies have shown promising results with inspiratory muscle training in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 yrs of age * Receiving SGLT2 inhibitors and spironolactone (and beta-blocker use for HFpEF patients with hypertension) for \>3 months * NYHA symptoms I-III * Body mass index ≤40 kg/m2 * Currently non-smokers with \<20 pack year history * Able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise) Exclusion Criteria: * Sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1 * Second or third degree heart block * Body mass index \>40 kg/m2 * Current smokers and/or smoking history \>20 pack years * Pregnant women (testing will be done by research team if requested) * 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) * Individuals who are not able to engage in exercise * Uremia, history of allergy to iodides * Peripheral artery disease * Alanine transaminase and/or aspartate transaminase greater than 2 times the upper limit of normal (via clinical record within the past 6 months) * Asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea * Ruptured eardrum or any other condition of the ear * History of spontaneous pneumothorax or osteoporosis with a history of rib fractures * History of lidocaine allergy. 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 this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Joshua Smith, PhD — Mayo Clinic
- Study coordinator: Eric Bruhn, M.A.
- Email: bruhn.eric@mayo.edu
- Phone: 507-266-2690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.