Heart Failure
Conditions
Brief summary
This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.
Interventions
OTHERInspiratory Muscle Training
Inspiratory muscle training (IMT) targets the inspiratory muscles and is used to improve inspiratory muscle strength.
Sponsors
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in inspiratory muscle blood flow demand | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in locomotor muscle blood flow | Baseline, 8 weeks | Locomotor muscle blood flows will be measured via indocyanine green dye venous bolus injection. This will be measured in umol. |
| Change in exercise tolerance | Baseline, 8 weeks | Exercise tolerance will be measured via submaximal exercise test. This will be measured in minutes. |
Countries
United States
Contacts
CONTACTEric Bruhn, M.A.
PRINCIPAL_INVESTIGATORJoshua Smith, PhD
Mayo Clinic
Outcome results
None listed