Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
68 participants
INTERVENTIONAL
2024-10-09
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Inspiratory muscle training (IMT) group
IMT performed at 40% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks.
Inspiratory Muscle Training
Inspiratory muscle training (IMT) targets the inspiratory muscles and is used to improve inspiratory muscle strength.
SHAM group
IMT performed at 2% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks.
Inspiratory Muscle Training
Inspiratory muscle training (IMT) targets the inspiratory muscles and is used to improve inspiratory muscle strength.
Interventions
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Inspiratory Muscle Training
Inspiratory muscle training (IMT) targets the inspiratory muscles and is used to improve inspiratory muscle strength.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Joshua R. Smith
Principal Investigator
Principal Investigators
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Joshua Smith, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Other Identifiers
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24-003293
Identifier Type: -
Identifier Source: org_study_id
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