Actively Recruiting

Age: 18Years +
All Genders
ID07093528

CMR Substudy of Coronary Sinus Reducer for Management of Symptomatic Heart Failure With Preserved Ejection Fraction Associated With Coronary Microvascular Dysfunction

Led by Mayo Clinic · Updated on 2026-02-27

25

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of coronary sinus (CS) reducer implantation in patients who have heart failure with preserved ejection fraction (HFpEF) combined with coronary microvascular dysfunction (CMD). The study aims to measure myocardial ischemia by using stress myocardial perfusion assessed through cardiovascular magnetic resonance (CMR). This observational research is sponsored by the Mayo Clinic and focuses on patients with these specific heart conditions. Participants diagnosed with HFpEF, non-obstructive coronary artery disease, and documented CMD will undergo a 50-minute non-invasive stress perfusion CMR test. The study involves observing changes in heart muscle blood flow by measuring the endocardial to epicardial perfusion ratio at the start and after 6 months. This diagnostic approach helps researchers understand how the CS reducer may influence heart muscle perfusion. Throughout the study, participants will be involved in CMR imaging sessions to assess heart function and blood flow under stress conditions. The primary outcome measured is the change in the endocardial to epicardial perfusion ratio between baseline and 6 months. Patients must consent to participate and be enrolled in the main CS reducer HFpEF study. The total duration includes initial imaging and follow-up after six months to monitor changes.

CONDITIONS

Brief Title

A Study Of CS Reducer For Symptomatic Heart Failure With HFpEF And CMD

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Enrollment in main CS-reducer HFPEF study IRB# 25-002292
Not Eligible

You will not qualify if you...

  • Metal implants that are not suitable for MRI
  • Inability or unwillingness to provide written informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 1 day

Participants undergo a non-invasive stress perfusion Cardiovascular Magnetic Resonance (CMR) lasting approximately 50 minutes.

1 visit (in-person)

Long-term Monitoring

Duration - 6 months

Participants are monitored for changes in heart function over 6 months after the diagnostic evaluation.

Trial Site Locations

Total: 1 location

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

D

Diana Albers

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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