Inspiratory Muscle Training in HFpEF

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Other: Inspiratory Muscle Training

• Registration Number: NCT06510231
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-19
• Status Verified: 2024-10
• Study Start: 2024-10-09
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory muscle training (IMT) group	Inspiratory Muscle Training	IMT performed at 40% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks.
SHAM group	Inspiratory Muscle Training	IMT performed at 2% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in inspiratory muscle blood flow demand	Baseline, 8 weeks	Inspiratory muscle blood flow demand will be measured via indocyanine green dye venous bolus injection. This will be measured in umol.

Secondary Outcome Measures

Name	Time	Method
Change in locomotor muscle blood flow	Baseline, 8 weeks	Locomotor muscle blood flows will be measured via indocyanine green dye venous bolus injection. This will be measured in umol.
Change in exercise tolerance	Baseline, 8 weeks	Exercise tolerance will be measured via submaximal exercise test. This will be measured in minutes.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States