Recruiting

Ex-CMR

Sponsor:

Mayo Clinic

Code:

NCT07401771

Conditions

Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Exercise Cardiovascular Magnetic Resonance

Study Details

Brief 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.

Conditions

Heart Failure With Preserved Ejection Fraction

Study ID

NCT07401771

Start date

Nov, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Informed consent obtained
2. Three groups will be enrolled:

1. HFpEF (cardiologist-adjudicated diagnosis as verified by PI, EF≥50%)
2. Non-cardiac dyspnea (patients have dyspnea but were found on invasive exercise testing not to have HFpEF).
3. Healthy volunteers with no history of dyspnea or effort intolerance.

Exclusion Criteria:

1. Contraindication for low-field CMR, as indicated in MRI safety screening checklist (Research Document #1)
2. Patient inability or unwillingness to undergo Ex-CMR
3. Cardiac implants, mechanical or biological valve, causing artifacts that compromise the quality of data
4. Hospitalization for heart failure in the preceding 30 days.
5. 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
6. Myocardial infarction or unstable angina pectoris
7. Planned coronary, carotid, or peripheral artery revascularization
8. 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).

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

HFpEF (Heart Failure with Preserved Ejection Fraction)

Non-cardiac dyspnea

Healthy Volunteers

Interventions

Exercise Cardiovascular Magnetic Resonance

Exercise Cardiovascular Magnetic Resonance is a non-invasive imaging technique that combines cardiovascular magnetic resonance (CMR) with exercise stress testing.

Primary outcome measure

  • Number of heart failure hospitalizations [ Time Frame: Baseline ]
  • Number of cardiac deaths [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Barry Borlaug, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-20.