Inspiratory Muscle Training in HFpEF
Recruiting · NCT06510231 · Interventional (participants receive a specific treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Inspiratory Muscle Training
What this trial is about
This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Mayo Clinic in Rochester - Rochester, Minnesota, United States