Heart FailureNCT06510231
Inspiratory Muscle Training in HFpEF
A study testing Inspiratory Muscle Training in people with Heart Failure, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Inspiratory Muscle Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2024to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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)
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Inspiratory Muscle Training in Heart Failure With Preserved Ejection Fraction
This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.
- Conditions
- Heart Failure
- Being tested
- Inspiratory Muscle Training
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
Inspiratory muscle training (IMT) targets the inspiratory muscles and is used to improve inspiratory muscle strength.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training (IMT) group | Experimental | IMT performed at 40% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks. Receives: 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. Receives: Other: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks
Secondary outcomes (2)
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.
Measured: Baseline, 8 weeks
Change in exercise tolerance
Exercise tolerance will be measured via submaximal exercise test. This will be measured in minutes.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start9 Oct 2024
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Joshua R. Smith, Mayo Clinic
- Investigators
- Joshua Smith, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510231
- Sponsor's protocol ID
- 24-003293
- Other IDs
- 1R01HL175086-01
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT06510231
- Acronym / sponsor ID
- 24-003293
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training (IMT) group | Experimental | Other: Inspiratory Muscle TrainingIMT performed at 40% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks. |
| SHAM group | Sham comparator | Other: Inspiratory Muscle TrainingIMT performed at 2% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle TrainingInspiratory muscle training (IMT) targets the inspiratory muscles and is used to improve inspiratory muscle strength. | Other | Inspiratory muscle training (IMT) group, SHAM group |
Primary outcome
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.
2 secondary outcomes
Change in locomotor muscle blood flow
Time frame: Baseline, 8 weeks
Change in exercise tolerance
Time frame: Baseline, 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Smith, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Heart Failure, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Bruhn, M.A. (507-266-2690, bruhn.eric@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inspiratory muscle blood flow demand (time frame: Baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.