Exercise cardiac MRI for heart failure with preserved ejection fraction

Exercise Cardiovascular Magnetic Resonance In Heart Failure With Preserved Ejection Fraction

This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT07401771 on ClinicalTrials.gov

What this trial studies

This observational study will internally validate a low-field exercise cardiovascular magnetic resonance (Ex-CMR) protocol as a noninvasive tool to diagnose, phenotype, and risk-stratify HFpEF. Three groups will be enrolled: patients with cardiologist-adjudicated HFpEF (EF ≥50%), patients with exertional dyspnea proven not to have HFpEF on invasive exercise testing, and healthy volunteers without dyspnea. Participants will undergo Ex-CMR imaging during exertion unless they meet MRI contraindications or have implants/artifacts or arrhythmias that compromise image quality. The study is a single-center protocol conducted at Mayo Clinic in Rochester, Minnesota to compare imaging results across the three cohorts.

Who should consider this trial

Good fit: Ideal candidates are adults with cardiologist-adjudicated HFpEF (EF ≥50%) who can undergo MRI, people with exertional dyspnea shown by invasive testing not to have HFpEF, and healthy volunteers without breathlessness.

Not a fit: Patients with MRI contraindications, implanted devices or valve prostheses that cause imaging artifact, recent heart failure hospitalization, or significant arrhythmias that disrupt imaging are unlikely to benefit or may be excluded.

Why it matters

Potential benefit: If successful, low-field Ex-CMR could offer a noninvasive way to diagnose and subtype HFpEF and help predict patient risk without routine invasive exercise testing.

How similar studies have performed: Exercise CMR at higher field strengths has previously detected hemodynamic abnormalities in HFpEF, but low-field exercise CMR is a newer approach that requires validation.

Eligibility criteria

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).

Where this trial is running

Rochester, Minnesota

• Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Barry Borlaug, MD — Mayo Clinic
• Study coordinator: Annabelle Fuenffinger

Conditions Heart Failure With Preserved Ejection Fraction