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

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clinicaltrials.gov/study/NCT03876223
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT038762230
Trial Recruitment Size
1800
Trial Sponsor
Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
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Trial Collaborator
University of Florida
University of Florida
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Clinical Trial Start Date
July 24, 2019
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Primary Completion Date
February 29, 2024
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Study Completion Date
February 29, 2024
0
Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Prospective0
Participating Facility
Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
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University of Florida
University of Florida
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Official Name
Women's Ischemia Syndrome Evaluation (WISE) Mechanisms of Coronary Microvascular Dysfunction Leading to Pre-Heart Failure With Preserved Ejection Fraction (HFpEF)0
Last Updated
November 15, 2022
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Study summary

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.

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