Exercise Cardiovascular Magnetic Resonance In Heart Failure With Preserved Ejection Fraction

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 Overview

• Status: Recruiting
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Diagnostic test: Exercise Cardiovascular Magnetic Resonance

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Annabelle Fuenffinger; Phone Number: 507-422-3801; Email: Fuenffinger.Annabelle@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Barry Borlaug, MD
      • Contact: Barry Borlaug, MD; Phone Number: (507) 255-1051; Email: Borlaug.Barry@mayo.edu
      • Contact: Dr. Borlaug's Research Team; Phone Number: (507) 255-2200; Email: Fuenffinger.Annabelle@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified from Mayo Clinic Cardiac Cath lab appointment lists.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers	Diagnostic test: Exercise Cardiovascular Magnetic Resonance; Exercise Cardiovascular Magnetic Resonance is a non-invasive imaging technique that combines cardiovascular magnetic resonance (CMR) with exercise stress testing.
HFpEF (Heart Failure with Preserved Ejection Fraction)	Diagnostic test: Exercise Cardiovascular Magnetic Resonance; Exercise Cardiovascular Magnetic Resonance is a non-invasive imaging technique that combines cardiovascular magnetic resonance (CMR) with exercise stress testing.
Non-cardiac dyspnea	Diagnostic test: Exercise Cardiovascular Magnetic Resonance; Exercise Cardiovascular Magnetic Resonance is a non-invasive imaging technique that combines cardiovascular magnetic resonance (CMR) with exercise stress testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
Number of cardiac deaths	The number of cardiac deaths will include all patients whose death is attributable to a cardiac cause.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of deaths	The number of deaths will include all patient deaths, regardless of cause.	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Barry Borlaug, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 25-012029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No