Recruiting

Inspiratory Muscle Training

Sponsor:

Mayo Clinic

Code:

NCT06510231

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Inspiratory Muscle Training

Study Details

Brief summary:

This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.

Conditions

Heart Failure

Study ID

NCT06510231

Start date

Oct 9, 2024

Status verified date

Jul, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Inspiratory muscle training (IMT) group

IMT performed at 40% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks.

sham comparator: SHAM group

IMT performed at 2% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks.

Interventions

Inspiratory Muscle Training

Inspiratory muscle training (IMT) targets the inspiratory muscles and is used to improve inspiratory muscle strength.

Primary outcome measure

  • Change in inspiratory muscle blood flow demand [ Time Frame: Baseline, 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

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.