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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT03876223
Status
Recruiting
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Conditions

  • Coronary Microvascular Dysfunction
  • Heart Failure With Preserved Ejection Fraction (HFpEF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jul 24, 2019
Status verified
Jun 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
180 participants (estimated)

Primary Outcome Measure

CMR imaging [ Time Frame: Baseline, Annual follow up ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
C. Noel Bairey Merz, MD
[email protected]
3102486960
University of FloridaGainesvilleFlorida32610
Eileen Handberg, PhD

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By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity of Florida· Gainesville, FL

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