CS reducer device for symptomatic HFpEF with coronary microvascular dysfunction
Official title: 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)
Run by Mayo Clinic · NCT07093528 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | October 16, 2025 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07093528 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.