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Recruiting

NCT Number: NCT06510231

Inspiratory Muscle Training in HFpEF

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inspiratory Muscle Training

Other

Inspiratory muscle training (IMT) targets the inspiratory muscles and is used to improve inspiratory muscle strength.

Primary outcomes

  1. Change in inspiratory muscle blood flow demand

    Time frame: 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 outcomes

  1. Change in locomotor muscle blood flow

    Time frame: Baseline, 8 weeks

    Locomotor muscle blood flows will be measured via indocyanine green dye venous bolus injection. This will be measured in umol.

  2. Change in exercise tolerance

    Time frame: Baseline, 8 weeks

    Exercise tolerance will be measured via submaximal exercise test. This will be measured in minutes.

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Bruhn, M.A.

CONTACT

[email protected]

507-266-2690

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Inspiratory Muscle Training in Heart Failure With Preserved Ejection Fraction

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 19, 2024
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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