Status:
RECRUITING
Inspiratory Muscle Training in HFpEF
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
October 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06510231
Start Date
October 9 2024
End Date
April 1 2028
Last Update
October 17 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905