Inspiratory Muscle Training in HFpEF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inspiratory Muscle Training.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Inspiratory Muscle Training in Heart Failure With Preserved Ejection Fraction
Overview
This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.
Interventions
- Other Inspiratory Muscle Training
Inspiratory muscle training (IMT) targets the inspiratory muscles and is used to improve inspiratory muscle strength.
Primary outcome measures
- Change in inspiratory muscle blood flow demand [Time frame: Baseline, 8 weeks]
Secondary outcome measures (2)
- Change in locomotor muscle blood flow [Time frame: Baseline, 8 weeks]
- Change in exercise tolerance [Time frame: Baseline, 8 weeks]
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)
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06510231 · 24-003293 · 1R01HL175086-01