NCT07401771

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

February 3, 2026

Last Update Submit

April 15, 2026

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Number of deaths

    Baseline

Study Arms (3)

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

Interventions

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.

HFpEF (Heart Failure with Preserved Ejection Fraction)Healthy VolunteersNon-cardiac dyspnea

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

  • Barry Borlaug, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annabelle Fuenffinger

CONTACT

507-422-3801Fuenffinger.Annabelle@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 10, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)