NCT07093528

Brief Summary

To evaluate the effect of CS reducer implantation in patients with HFPEF and CMD on myocardial ischemia, measured by stress myocardial perfusion using cardiovascular magnetic resonance (CMR)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
15mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Oct 2025Aug 2027

First Submitted

Initial submission to the registry

July 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 16, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

February 27, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

July 23, 2025

Last Update Submit

February 24, 2026

Conditions

Heart Failure With Preserved Ejection FractionCoronary Microvascular Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in endocardial:epicardial perfusion ratio

    Endocardial:Epicardial Perfusion Ratio is a measure of myocardial blood flow and will be determined by Cardiovascular magnetic resonance (CMR)

    Baseline, 6 Months

Study Arms (1)

Heart Failure with a Preserved Ejection Fraction (HFpEF)

Subjects with diagnosed Heart failure with a preserved ejection fraction (HFpEF), non-obstructive Coronary Artery Disease (CAD), and have documented CMD.

Diagnostic Test: Cardiovascular Magnetic Resonance (CMR)

Interventions

Cardiovascular Magnetic Resonance (CMR)DIAGNOSTIC_TEST

Patients will consent to undergo a 50-minute non-invasive stress perfusion CMR.

Heart Failure with a Preserved Ejection Fraction (HFpEF)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects included in the main CS-reducer HFPEF study (IRB# 25-002292)

You may qualify if:

  • Age ≥18
  • Enrollment in main CS-reducer HFPEF study IRB# 25-002292

You may not qualify if:

  • Metal implants that are not suitable for MRI
  • Inability or unwillingness of individual to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

  • Claire Raphael, M.B.B.S., Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Albers

CONTACT

507-255-6884albers.diana2@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 30, 2025

Study Start

October 16, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)