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

NCT ID: NCT07093528

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-08-31

Brief Summary

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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)

Detailed Description

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Conditions

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Heart Failure With Preserved Ejection Fraction Coronary Microvascular Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cardiovascular Magnetic Resonance (CMR)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Cardiovascular Magnetic Resonance (CMR)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Claire E. Raphael

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claire Raphael, M.B.B.S., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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25-005812

Identifier Type: -

Identifier Source: org_study_id

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