Heart Failure With Preserved Ejection FractionNCT07093528
A Study Of CS Reducer For Symptomatic Heart Failure With HFpEF And CMD
An observational study of Heart Failure With Preserved Ejection Fraction and Coronary Microvascular Dysfunction, run by Mayo Clinic at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Coronary Microvascular Dysfunction
- What is being tested?
- Cardiovascular Magnetic Resonance (CMR)
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2025to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects included in the main CS-reducer HFPEF study (IRB# 25-002292)
Who may be able to join
- Age ≥18
- Enrollment in main CS-reducer HFPEF study IRB# 25-002292
Who cannot join
- Metal implants that are not suitable for MRI
- Inability or unwillingness of individual to give written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Diana Albers, 507-255-6884, albers.diana2@mayo.edu
Claire Raphael, M.B.B.S., Ph.D.
About this study
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)
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)
- Being tested
- Cardiovascular Magnetic Resonance (CMR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Magnetic Resonance (CMR)Diagnostic test
Patients will consent to undergo a 50-minute non-invasive stress perfusion CMR.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start16 Oct 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire E. Raphael, Mayo Clinic
- Investigators
- Claire Raphael, M.B.B.S., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093528
- Sponsor's protocol ID
- 25-005812
- Status last verified
- Jan 2026
- First submitted
- 23 Jul 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07093528
- Acronym / sponsor ID
- 25-005812
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure with a Preserved Ejection Fraction (HFpEF) | – | Diagnostic Test: Cardiovascular Magnetic Resonance (CMR)Subjects with diagnosed Heart failure with a preserved ejection fraction (HFpEF), non-obstructive Coronary Artery Disease (CAD), and have documented CMD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects included in the main CS-reducer HFPEF study (IRB# 25-002292)
Key inclusion criteria (2 listed)
- Age ≥18
- Enrollment in main CS-reducer HFPEF study IRB# 25-002292
Key exclusion criteria (2 listed)
- Metal implants that are not suitable for MRI
- Inability or unwillingness of individual to give written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular Magnetic Resonance (CMR)Patients will consent to undergo a 50-minute non-invasive stress perfusion CMR. | Diagnostic test | Heart Failure with a Preserved Ejection Fraction (HFpEF) |
Primary outcome
Change in endocardial:epicardial perfusion ratio
Time frame: Baseline, 6 Months
Endocardial:Epicardial Perfusion Ratio is a measure of myocardial blood flow and will be determined by Cardiovascular magnetic resonance (CMR)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claire Raphael, M.B.B.S., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction and Coronary Microvascular Dysfunction, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Albers (507-255-6884, albers.diana2@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endocardial:epicardial perfusion ratio (time frame: Baseline, 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.