Recruiting

WISE

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT03876223

Conditions

Coronary Microvascular Dysfunction

Heart Failure With Preserved Ejection Fraction (HFpEF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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)

Study ID

NCT03876223

Start date

Jul 24, 2019

Status verified date

Aug, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion:

1. 180 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.
2. Preserved left ventricular ejection fraction (EF) ≥45%
3. Be > 18 years old
4. Be able to meet the requirement for a cardiac MRI, which means no metal devices in your chest, no claustrophobia and no angioedema
5. Be competent to give informed consent

Exclusion:

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

Study Design

Enrollment

180 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • CMR imaging [ Time Frame: Baseline, Annual follow up ]
  • Rest-stress Millar pressure-volume measurement [ Time Frame: Baseline ]

Central Contacts and Locations

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-08-26.