NCT07086131 A Study Investigating the Impact of IMT With CR On Exercise Responses In HF
| NCT ID | NCT07086131 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-09-04 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-09-04 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to compare the impact of inspiratory muscle training (IMT) combined with cardiac rehabilitation (CR) on cardiovascular function in patients with heart failure.
Eligibility Criteria
Inclusion Criteria HFrEF Patients: (≥18 yrs) receiving guideline directed pharmacologic medical therapy for \>6 weeks (those with contraindications to medical therapy will meet inclusion criteria), NYHA symptoms I-III, no hospitalizations in the \>3 months, have a body mass index ≤45 kg/m2, currently be non-smokers with \<30 pack year history and be able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise). Exclusion Criteria 1. sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1; 2. second or third degree heart block; 3. body mass index \>45 kg/m2; 4. current smokers and/or smoking history \>30 pack years; 5. pregnant women (testing will be done by research team if requested); 6. 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); 7. individuals who are not able to engage in exercise; 8. symptomatic peripheral artery disease; 9. asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea; 10. ruptured eardrum or any other condition of the ear; 11. history of spontaneous pneumothorax or osteoporosis with a history of rib fractures; 12. history of lung disease. 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.
Contact & Investigator
Joshua Smith, Ph.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT07086131 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07086131 currently recruiting?
Yes, NCT07086131 is actively recruiting participants. Contact the research team at bruhn.eric@mayo.edu for enrollment information.
Where is the NCT07086131 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07086131 clinical trial?
NCT07086131 is sponsored by Mayo Clinic. The principal investigator is Joshua Smith, Ph.D. at Mayo Clinic. The trial plans to enroll 70 participants.
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