Inspiratory Muscle Training in HFpEF

Mayo Clinic

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: Inspiratory Muscle Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06510231

1R01HL175086-01 (U.S. NIH Grant/Contract)

24-003293

Details and patient eligibility

About

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

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

Inspiratory muscle training (IMT) group

Experimental group

Description:

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

Treatment:

Other: Inspiratory Muscle Training

SHAM group

Sham Comparator group

Description:

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

Treatment:

Other: Inspiratory Muscle Training