Actively Recruiting
WISE CVD - Continuation (WISE HFpEF)
Led by Cedars-Sinai Medical Center · Updated on 2025-07-24
220
Participants Needed
1
Research Sites
743 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Women's Ischemia Study Evaluation (WISE), a cohort study of over 1000 women, has made many contributions to the understanding of cardiovascular disease. A milestone acknowledged in the 2011 AHA Herrick Lecture is the role of Coronary Microvascular Dysfunction (CMD) in women with symptoms/signs of ischemia without obstructive coronary artery disease (CAD). While in 1996, CMD was considered "an imaging artifact", in 2013, it is a widely accepted as a pathophysiologic process requiring systematic cohesive scientific pursuit. CMD is prevalent, associated with adverse clinical outcomes, poor quality of life and healthcare costs rivaling obstructive CAD. There are 2-3 million US women with CMD, and 100,000 new cases projected annually placing CMD prevalence, morbidity and costs higher than all female reproductive cancers combined. Among women with ischemia, preserved ejection fraction and no obstructive CAD, it has been observed that there are relatively more new onset heart failure (HF) hospitalizations than nonfatal myocardial infarction (MI). It has been hypothesized that CMD contributes to left ventricular (LV) diastolic dysfunction and subsequent heart failure with preserved ejection fraction (HFpEF). Preliminary data further suggests that left ventricular diastolic dysfunction is linked to CMD via a mechanism of augmentation and/or perpetuation by cardiomyocyte fat accumulation. HFpEF is prevalent in women and older men, but poorly understood. Mechanistic understanding is critical to HFpEF intervention and guideline development. The study hypotheses are as follows: 1. Risk factor conditions (hypertension, dyslipidemia, dysglycemia, loss of estrogen) promote an inflammatory and pro-oxidative state making the microvasculature vulnerable; 2. Vulnerable coronary microvasculature becomes dysregulated (sympathetic nervous system activation, endothelial dysfunction, changes in vascular smooth muscle activation, spasm) causing repeated episodes of transient ischemia; 3. Repeated ischemia-reperfusion episodes facilitate preconditioning with preservation of cardiomyocyte contractile and microvascular function against ischemic injury; 4. Ischemia-reperfusion and preconditioning lead to cardiomyocyte fat accumulation and relaxation impairment resulting in diastolic dysfunction and heart failure with preserved ejection fraction (HFpEF).
CONDITIONS
Official Title
WISE CVD - Continuation (WISE HFpEF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic angina or anginal equivalent for women undergoing coronary angiography
- Age 18 years or older
- Willing to provide written informed consent
- Signs and symptoms of heart failure for hospitalized HFpEF patients
- Preserved left ventricular ejection fraction (LVEF ≥ 45%) prior to study entry for HFpEF patients
- Structural evidence of cardiovascular abnormalities such as elevated brain natriuretic peptide, abnormal filling or relaxation, left ventricular hypertrophy, or increased left atrial size for HFpEF patients
- Evidence of elevated filling pressures (LVEDP or PCWP > 15 mmHg at rest and/or with exercise ≥ 25 mmHg, exercise E/e' > 13, elevated BNP, or use of diuretic) for HFpEF patients
You will not qualify if you...
- Obstructive coronary artery disease (≥ 50% narrowing in at least one major coronary artery) for women undergoing angiography
- Recent STEMI (3-7 days post MI) or acute coronary syndrome/NSTEMI with recent ischemic symptoms within 12 to 24 hours before procedure
- Primary valvular heart disease requiring valve repair or replacement
- Cardiogenic shock or need for inotropic or intra-aortic balloon support, or LVEF less than 45%
- Prior or planned coronary interventions like PCI or CABG for obstructive coronary atherosclerosis
- Non-cardiac illness with life expectancy less than four years
- Inability to give informed consent
- Chest pain from non-ischemic causes (pericarditis, pulmonary embolism, pleurisy, pneumonia, esophageal spasm, etc.)
- Contraindications to cardiac MRI such as internal cardiac defibrillator, untreatable claustrophobia, or known angioedema
- Contraindications to adenosine or regadenoson including severe COPD and asthma
- End stage renal or liver disease
- Intermediate coronary stenoses (>20% but <50%) evaluated by fractional flow reserve showing flow obstruction
- Allergy to gadolinium
- For HFpEF patients: LVEF less than 45%, recent acute coronary syndrome or myocardial infarction within 3 months unless LVEF ≥ 45%
- Moderate or greater valvular heart disease, primary cardiomyopathies, constrictive pericarditis, high-output heart failure, or right ventricular myopathies
- Acute decompensated heart failure requiring therapy due to trauma or infection
- Alternative causes of shortness of breath such as severe pulmonary disease, hemoglobin <10 g/dl, or BMI >40 kg/m2
- High systolic blood pressure ≥180 mmHg or 150-180 mmHg unless on three or more antihypertensives
- Obstructive stenoses (≥ 50% narrowing) on coronary CT angiography
- End stage renal or liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Women's Heart Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
B
BSWHC Research, MS
CONTACT
F
Fatima Bataz, BS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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