Inspiratory Muscle Training in HFpEF

NCT06510231 | Recruiting DMC

• 2 other identifiers: 24-0032931R01HL175086-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

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.

  Baseline, 8 weeks

Secondary Outcomes (2)

• Change in locomotor muscle blood flow

  Baseline, 8 weeks

• Change in exercise tolerance

  Baseline, 8 weeks

Study Arms (2)

Inspiratory muscle training (IMT) group

EXPERIMENTAL

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

Other: Inspiratory Muscle Training

SHAM group

SHAM COMPARATOR

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

Other: Inspiratory Muscle Training

Interventions

Inspiratory Muscle Training OTHER

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

Inspiratory muscle training (IMT) group; SHAM group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Joshua Smith, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Bruhn, M.A.

CONTACT

507-266-2690; bruhn.eric@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: October 9, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)