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.
Conditions:
🦠 Heart Failure
🗓️ Study Start (Actual) August 2024
🗓️ Primary Completion (Estimated) April 2028
✅ Study Completion (Estimated) April 2028
👥 Enrollment (Estimated) 68
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 July 2024
  • First Submitted that Met QC Criteria 15 July 2024
  • First Posted 19 July 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 July 2024
  • Last Update Posted 23 July 2024
  • Last Verified July 2024