Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction

Overview

About this study

The purpose of this study is to determine the impact of inspiratory muscle training on inspiratory muscle blood regulation during exercise in heart failure patients with preserved ejection fraction (HFpEF).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/17/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joshua Smith, Ph.D., M.S.

Open for enrollment

Contact information:

Eric Bruhn M.A.

(507) 422-0220

Bruhn.Eric@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20570801

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