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Inspiratory Muscle Training in HFpEF

RECRUITINGN/ASponsored by Mayo Clinic
Actively Recruiting
PhaseN/A
SponsorMayo Clinic
Started2024-10-09
Est. completion2028-04
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers 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.

Conditions2

Heart DiseaseHeart Failure

Locations1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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