Heart Failure With Preserved Ejection FractionNCT07401771
Exercise Cardiovascular Magnetic Resonance In Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to internally validate low-field Ex-CMR as a noninvasive tool for diagnosing, phenotyping, and risk stratifying HFpEF in patients with exertional dyspnea. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Exercise Cardiovascular Magnetic Resonance
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Mar 2028
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be identified from Mayo Clinic Cardiac Cath lab appointment lists.
Who may be able to join
- Informed consent obtained
- Three groups will be enrolled:
- HFpEF (cardiologist-adjudicated diagnosis as verified by PI, EF≥50%)
- Non-cardiac dyspnea (patients have dyspnea but were found on invasive exercise testing not to have HFpEF).
- Healthy volunteers with no history of dyspnea or effort intolerance.
Who cannot join
- Contraindication for low-field CMR, as indicated in MRI safety screening checklist (Research Document #1)
- Patient inability or unwillingness to undergo Ex-CMR
- Cardiac implants, mechanical or biological valve, causing artifacts that compromise the quality of data
- Hospitalization for heart failure in the preceding 30 days.
- Large R-R interval variation, caused by frequent premature ventricular contractions or non-sinus rhythms such as persistent atrial fibrillation, which, in the opinion of the investigators, compromises the quality of data acquisition, image analysis and disrupts the consistency of the cohorts
- Myocardial infarction or unstable angina pectoris
- Planned coronary, carotid, or peripheral artery revascularization
- Other causes of dyspnea as indicated in patients' medical history based upon the opinion of the PI, such as restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, primary pulmonary arterial hypertension, more than moderate chronic obstructive pulmonary disease, right heart failure due to pulmonary disease, complex congenital heart disease, severe anemia, or more than moderate mitral or aortic heart valve disease).
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 in Rochester
Rochester, Minnesota, 55905
Dr. Borlaug's Research Team, (507) 255-2200, Fuenffinger.Annabelle@mayo.edu
Barry Borlaug, MD, (507) 255-1051, Borlaug.Barry@mayo.edu
About this study
The purpose of this study is to internally validate low-field Ex-CMR as a noninvasive tool for diagnosing, phenotyping, and risk stratifying HFpEF in patients with exertional dyspnea.
- Being tested
- Exercise Cardiovascular Magnetic Resonance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Cardiovascular Magnetic ResonanceDiagnostic test
Exercise Cardiovascular Magnetic Resonance is a non-invasive imaging technique that combines cardiovascular magnetic resonance (CMR) with exercise stress testing.
| Study group | Role | What they receive |
|---|---|---|
| HFpEF (Heart Failure with Preserved Ejection Fraction) | Not described Receives: Diagnostic Test: Exercise Cardiovascular Magnetic Resonance | |
| Non-cardiac dyspnea | Not described Receives: Diagnostic Test: Exercise Cardiovascular Magnetic Resonance | |
| Healthy Volunteers | Not described Receives: Diagnostic Test: Exercise Cardiovascular Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of heart failure hospitalizations
Number of heart failure hospitalizations will be determined by the number of patients admitted to the hospital due to heart failure complications.
Measured: Baseline
Number of cardiac deaths
The number of cardiac deaths will include all patients whose death is attributable to a cardiac cause.
Measured: Baseline
Secondary outcomes (1)
Number of deaths
The number of deaths will include all patient deaths, regardless of cause.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry Borlaug, Mayo Clinic
- Investigators
- Barry Borlaug, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401771
- Sponsor's protocol ID
- 25-012029
- Status last verified
- Aug 2026
- First submitted
- 3 Feb 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Cardiovascular Magnetic Resonance In Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT07401771
- Acronym / sponsor ID
- 25-012029
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 Feb 2026 (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.
The purpose of this study is to internally validate low-field Ex-CMR as a noninvasive tool for diagnosing, phenotyping, and risk stratifying HFpEF in patients with exertional dyspnea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFpEF (Heart Failure with Preserved Ejection Fraction) | – | Diagnostic Test: Exercise Cardiovascular Magnetic Resonance |
| Non-cardiac dyspnea | – | Diagnostic Test: Exercise Cardiovascular Magnetic Resonance |
| Healthy Volunteers | – | Diagnostic Test: Exercise Cardiovascular Magnetic Resonance |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be identified from Mayo Clinic Cardiac Cath lab appointment lists.
Key inclusion criteria (5 listed)
- Informed consent obtained
- Three groups will be enrolled:
Key exclusion criteria (8 listed)
- Contraindication for low-field CMR, as indicated in MRI safety screening checklist (Research Document #1)
- Patient inability or unwillingness to undergo Ex-CMR
- Cardiac implants, mechanical or biological valve, causing artifacts that compromise the quality of data
- Hospitalization for heart failure in the preceding 30 days.
- Large R-R interval variation, caused by frequent premature ventricular contractions or non-sinus rhythms such as persistent atrial fibrillation, which, in the opinion of the investigators, compromises the quality of data acquisition, image analysis and disrupts the consistency of the cohorts
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 |
|---|---|---|
| Exercise Cardiovascular Magnetic ResonanceExercise Cardiovascular Magnetic Resonance is a non-invasive imaging technique that combines cardiovascular magnetic resonance (CMR) with exercise stress testing. | Diagnostic test | HFpEF (Heart Failure with Preserved Ejection Fraction), Healthy Volunteers, Non-cardiac dyspnea |
Primary outcome
Number of heart failure hospitalizations
Time frame: Baseline
Number of heart failure hospitalizations will be determined by the number of patients admitted to the hospital due to heart failure complications.
Number of cardiac deaths
Time frame: Baseline
The number of cardiac deaths will include all patients whose death is attributable to a cardiac cause.
1 secondary outcome
Number of deaths
Time frame: Baseline
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 20 Aug 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.
Barry Borlaug, MD 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, 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 5 inclusion and 8 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 20 Aug 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 Annabelle Fuenffinger (507-422-3801, Fuenffinger.Annabelle@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of heart failure hospitalizations (time frame: Baseline). The study lists 2 primary outcomes in all. 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 20 Aug 2026.