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

NCT03876223 | Recruiting

• 1 other identifier: 54999
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Coronary Microvascular Dysfunction (CMD); Coronary Vascular Dysfunction (CVD); Coronary angiography; Magnetic resonance imaging (MRI)

Outcome Measures

Primary Outcomes (2)

• CMR imaging

  Change from Baseline at 1 year follow up will be assessed.

  Baseline, Annual follow up

• Rest-stress Millar pressure-volume measurement

  LV diastolic function will be measured using LV end-diastolic pressure, minimal rate of LV pressure change (dP/dtmin).

  Baseline

Secondary Outcomes (4)

• Questionnaire

  Baseline, 6 week, quarterly(year 1) and annual follow up

• Questionnaire WISE Symptoms History

  Baseline, quarterly(year 1) and annual follow up

• SEATTLE ANGINA QUESTIONNAIRE

  Baseline, 6 week and annual follow up

• Duke Activity Status Inventory (DASI)

  Baseline, 6 week and annual follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women undergoing invasive coronary angiography for suspected ischemia with no obstructive CAD, defined as ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery.

You may qualify if:

• symptomatic men and women undergoing invasive coronary angiography for suspected ischemia with no obstructive CAD, defined as ≥50% luminal diameter stenosis in ≥1 epicardial coronary artery.
• Preserved left ventricular ejection fraction (EF) ≥45%
• Be \> 18 years old
• Be able to meet the requirement for a cardiac MRI, which means no metal devices in your chest, no claustrophobia and no angioedema
• Be competent to give informed consent

You may not qualify if:

• Subjects with severe or chronic kidney disease (CKD) with GFR\<405 or acute kidney injury
• Subjects with allergy to animal dander will be excluded since imaging will be done in BIRI (BIRI scanners are also used to image animals).
• Subjects who have had four or more prior previous gadolinium contrast scans
• Allergy/ hypersensitivity to adenosine, gadolinium, aminophylline or regadenoson
• Second- or third-degree A-V block
• Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker)
• Subjects with mild to severe asthma

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• University of Florida: collaborator

Study Sites (2)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Related Publications (1)

• Takahashi T, Wei J, Iribarren AC, Gulati M, Cook-Wiens G, Nelson MD, Sharif B, Handberg EM, Anderson RD, Petersen J, Berman DS, Pepine CJ, Merz CNB. Rationale and design of the women's ischemia syndrome evaluation mechanisms of coronary microvascular dysfunction leading to preheart failure with preserved ejection fraction (WISE Pre-HFPEF). Am Heart J. 2025 Jun;284:47-56. doi: 10.1016/j.ahj.2025.02.017. Epub 2025 Feb 24.

  PMID: 40010584 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

A maximum of 45 mL of whole blood will be collected, which will be processed and stored as serum, plasma, and DNA for biomarkers and for genetic testing.

Study Officials

• C. Noel Bairey Merz, MD, FACC

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Tovar

CONTACT

310-248-6960; nicole.tovar@cshs.org

Lorena Guzman

CONTACT

3102486960; lorena.guzman@cshs.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 15, 2019
• Study Start: July 24, 2019
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (2)