CS reducer device for symptomatic HFpEF with coronary microvascular dysfunction
CMR Substudy of Coronary Sinus Reducer for the Management of Symptomatic Heart Failure With a Preserved Ejection Fraction (HFpEF) Associated With Coronary Microvascular Dysfunction (CMD)
This study will test whether implanting a coronary sinus (CS) reducer reduces heart muscle ischemia on stress CMR in adults with HFpEF and coronary microvascular dysfunction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07093528 on ClinicalTrials.gov |
What this trial studies
Adults enrolled in the main CS-reducer HFpEF study who have HFpEF and documented coronary microvascular dysfunction will undergo cardiovascular magnetic resonance (CMR) stress myocardial perfusion imaging to measure ischemia. Imaging will be used to compare myocardial perfusion before and after CS reducer implantation in an observational design without randomization. The protocol relies on serial stress CMR scans and clinical follow-up at Mayo Clinic in Rochester, Minnesota. Data will be analyzed to see if changes in perfusion correspond with the device placement and clinical status.
Who should consider this trial
Good fit: Adults (age ≥18) with HFpEF and documented coronary microvascular dysfunction who are enrolled in the main CS-reducer HFpEF study and are eligible for a CS reducer and MRI scans are appropriate candidates.
Not a fit: Patients without coronary microvascular dysfunction, those whose symptoms are driven by non-ischemic mechanisms, or those who cannot undergo MRI are unlikely to benefit from this imaging-focused substudy.
Why it matters
Potential benefit: If successful, the CS reducer could lessen myocardial ischemia and related symptoms in patients with HFpEF and CMD, potentially improving exercise tolerance and quality of life.
How similar studies have performed: Coronary sinus reducer devices have shown symptomatic benefit in patients with refractory angina due to epicardial coronary disease, but their use specifically for HFpEF with CMD is relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 * Enrollment in main CS-reducer HFPEF study IRB# 25-002292 Exclusion Criteria: * Metal implants that are not suitable for MRI * Inability or unwillingness of individual to give written informed consent.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Claire Raphael, M.B.B.S., Ph.D. — Mayo Clinic
- Study coordinator: Diana Albers
- Email: albers.diana2@mayo.edu
- Phone: 507-255-6884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.