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NCT03876223 · ClinicalTrials.gov record · last posted 2026-08-26

Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF

StatusRecruiting
PhaseNot specified
Started2019-07-24
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from the ClinicalTrials.gov record
The purpose of this study is to examine small vessel disease (a condition in which the small arteries in the heart become narrowed). The investigators want to know how the small vessel disease contributes to pre-HFpEF (a condition with inadequate heart muscle function in the setting of preserved muscle pumping) and to better identify potential treatment for prevention of HFpEF. The main procedures of this study include up to 2 clinic visits (initial visit and a second clinical visit only if participants are unable to complete all research procedures at the initial visit); a 6-week phone interview visit, 4 quarterly follow-up phone interview visits in year 1; year 1 follow up cardiac MRI based on availability and ongoing annual follow-up phone interview visits to track progress. If participants choose to take part in this study, participants direct participation will end after 1 year, participants will then have the option of participating in ongoing annual check-in calls. Participants will be asked to undergo a physical exam and provide a completed medical history; complete a Cardiovascular (or Cardiac) Magnetic Resonance Imaging (CMRI) with contrast agent; complete questionnaires to describe heart symptoms and overall quality of life status; undergo blood draws to provide blood samples for research testing, and allow the study team to have access to medical records.

Protocol amendment history 2 changes detected by DataLookout

2026-08-27
critical
Primary completion pushed: 2026-02-28 → 2027-02-28
2026-08-27
minor
Completion pushed: 2026-02-28 → 2027-02-28
Trial Details
NCT Number NCT03876223
Lead Sponsor Cedars-Sinai Medical Center
Collaborators: University of Florida
Conditions Coronary Microvascular Dysfunction, Heart Failure With Preserved Ejection Fraction (HFpEF)
Enrollment 180 participants
Start Date 2019-07-24
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-26