Recruiting NCT07401771
Exercise Cardiovascular Magnetic Resonance In Heart Failure With Preserved Ejection Fraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise Cardiovascular Magnetic Resonance.
- Who it may be relevant to
- Registry conditions: Heart Failure With Preserved Ejection Fraction. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Number of heart failure hospitalizations [Time frame: Baseline]
- Number of cardiac deaths [Time frame: Baseline]
Secondary outcome measures (1)
- Number of deaths [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07401771 · 25-012029