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RecruitingNCT06510231Updated Aug 7, 2026

Inspiratory Muscle Training in HFpEF

An interventional study of Inspiratory Muscle Training in Heart Failure, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Oct 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 68 is close to the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Inspiratory muscle training (IMT) group

    IMT performed at 40% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks.

    Other: Inspiratory Muscle Training

  • Sham comparator
    SHAM group

    IMT performed at 2% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks.

    Other: Inspiratory Muscle Training

Interventions

  • OtherInspiratory Muscle Training

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

06

What researchers measure

Primary outcomes

  1. Change in inspiratory muscle blood flow demand

    Inspiratory muscle blood flow demand will be measured via indocyanine green dye venous bolus injection. This will be measured in umol.

    Time frame: Baseline, 8 weeks

Secondary outcomes

  1. Change in locomotor muscle blood flow

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

    Time frame: Baseline, 8 weeks

  2. Change in exercise tolerance

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

    Time frame: Baseline, 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06510231
Lead sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Joshua R. Smith (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jul 19, 2024
Start date
Oct 9, 2024
Primary completion
Apr 2028 (estimated)
Completion
Apr 2028 (estimated)
Last update
Aug 7, 2026

Study contacts

Eric Bruhn, M.A.
Contact
bruhn.eric@mayo.edu
507-266-2690
Joshua Smith, PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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