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Inspiratory Muscle Training in HFpEF

Inspiratory Muscle Training in Heart Failure With Preserved Ejection Fraction

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests training for the muscles used to breathe in. It looks at how these muscles work during exercise in adults with HFpEF, a type of heart failure where the heart still squeezes normally.

This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Taking SGLT2 inhibitors and spironolactone for more than 3 months. Those with high blood pressure must also be taking a beta-blocker.
  • Heart failure symptoms in NYHA classes I–III, ranging from no limits on activity to marked limits.
  • Body mass index (BMI), a measure of weight compared with height, of 40 or less.
  • Not smoking now, with less than 20 pack-years of past smoking. One pack-year means smoking one pack a day for one year.
  • Able to exercise, without major bone, joint, or muscle problems that limit exercise.

Who can't join

  • Certain dangerous heart rhythms within 21 days before visit 1, or second- or third-degree heart block, a problem with the heart’s electrical signals.
  • BMI over 40; current smoking or more than 20 pack-years of past smoking; pregnancy; or inability to exercise.
  • Kidney filtering rate below 30, waste buildup in the blood called uremia, or liver blood tests called ALT or AST above twice the normal upper limit.
  • Peripheral artery disease, which reduces blood flow to the limbs, or an allergy to iodides or lidocaine.
  • Asthma with poor awareness of symptoms and frequent, severe flare-ups, or unusually low awareness of shortness of breath.
  • A torn eardrum or another ear condition; a past lung collapse that happened on its own; or weak bones called osteoporosis with past rib fractures.
  • For the optional DEXA body scan: recently receiving contrast material for digestive tract imaging or radioactive materials for testing.
  • For the optional DEXA body scan: severe wear-and-tear changes or changes from broken bones in the areas being measured, or inability to get into position or stay still.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MN