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Clinical Trials/NCT06510231
NCT06510231
Recruiting
Not Applicable

Inspiratory Muscle Training in Heart Failure With Preserved Ejection Fraction

Mayo Clinic1 site in 1 country68 target enrollmentOctober 9, 2024
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Mayo Clinic
Enrollment
68
Locations
1
Primary Endpoint
Change in inspiratory muscle blood flow demand
Status
Recruiting
Last Updated
6 months ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
October 9, 2024
End Date
April 1, 2028
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joshua R. Smith

Principal Investigator

Mayo Clinic

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)

Outcomes

Primary Outcomes

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

  • Change in locomotor muscle blood flow(Baseline, 8 weeks)
  • Change in exercise tolerance(Baseline, 8 weeks)

Study Sites (1)

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