NCT06510231
Recruiting
Not Applicable
Inspiratory Muscle Training in Heart Failure With Preserved Ejection Fraction
ConditionsHeart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Mayo Clinic
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Change in inspiratory muscle blood flow demand
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.
Investigators
Joshua R. Smith
Principal Investigator
Mayo Clinic
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Change in inspiratory muscle blood flow demand
Time Frame: 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 Outcomes
- Change in locomotor muscle blood flow(Baseline, 8 weeks)
- Change in exercise tolerance(Baseline, 8 weeks)
Study Sites (1)
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