WISE CVD - Continuation (WISE HFpEF) for Microvascular Coronary Dysfunction and Cardiovascular Disease
This observational study, called WISE HFpEF, is looking at how problems with small blood vessels in the heart (Microvascular Coronary Dysfunction or CMD) are linked to a type of heart failure called HFpEF (Heart Failure with preserved Ejection Fraction). Researchers are using several procedures to understand this connection, including Coronary Angiography (an X-ray to see heart blood vessels), Coronary Reactivity Testing (examining how heart blood vessels respond to medicines), and Cardiac Magnetic Resonance Imaging (a high-resolution heart scan). They are also using Cardiac Magnetic Resonance Angiography and Computed Coronary Tomographic Angiography to get detailed images of the heart. The study aims to enroll 220 participants, including women with chest pain and men and women hospitalized for HFpEF. The main goal is to track cardiovascular events for up to 30 years to see how CMD affects long-term heart health. The current recruitment status is unclear.
- Study design
- This is an observational study planning to enroll 220 participants, including women with symptomatic angina and men and women hospitalized for HFpEF.
- What's involved
- You would undergo procedures like Coronary Angiography, Coronary Reactivity Testing, Cardiac Magnetic Resonance Imaging, Cardiac Magnetic Resonance Angiography, and Computed Coronary Tomographic Angiography. Handgrip, mild leg exercise, and a brief Valsalva Maneuver will also be conducted.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for cardiovascular events for up to 30 years.
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NCT02582021
WISE CVD - Continuation (WISE HFpEF)
Recruiting
Not specifiedAges 18+ObservationalCedars-Sinai Medical CenterInvestigator-initiated
~220 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Coronary AngiographyCoronary Reactivity TestingCardiac Magnetic Resonance ImagingCardiac Magnetic Resonance AngiographyComputed Coronary Tomographic AngiographyRest-Stress Millar Testing
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cardiovascular (CV) events
Measured over up to 30 years
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- C. Noel Bairey Merz, MD, FACC · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Symptomatic angina or anginal equivalent
Age ≥ 18
Participant is willing to give written informed consent
Age ≥ 18
Signs and symptoms of heart failure
Preserved ejection fraction, left ventricular ejection fraction (LVEF) ≥45% prior to study entry.
Structural evidence of cardiovascular abnormalities: elevated brain naturetic peptide, evidence of abnormal filling or relaxation, left ventricular hypertrophy, or an increased left atrial size
Evidence of elevated filling pressures: LVEDP or PCWP at rest \> 15 mmHg and/or with exercise ≥25 mmHg, exercise E/e' \>13, elevated BNP, or use of diuretic
Participant is willing to give written informed consent
Exclusion
Obstructive CAD ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery
STEMI within 3-7 days post MI, or Acute coronary syndrome/NSTEMI with with symptoms or signs of acute myocardial ischemia within the last 12 to 24 hours prior to the research procedure, as outlined in ACC/AHA guidelines.
Primary valvular heart disease clearly indicating the need for valve repair or replacement
Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support or LVEF\<45%
Prior or planned percutaneous coronary intervention or coronary artery bypass grafting for obstructive coronary atherosclerosis
Non-cardiac illness with a life expectancy \< four years
Unable to give informed consent
Chest pain which has an alternative non-ischemic etiology, i.e. pericarditis, pulmonary embolism, pleurisy, pneumonia, esophageal spasm, etc.
Contraindications to CMRI, 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
Women with intermediate coronary stenoses (\>20% but \<50% luminal diameter stenosis assessed visually at the time of angiography) will undergo clinically indicated fractional flow reserve (FFR) based on the judgment of the operator; those determined to have flow-obstructing stenosis will be excluded.
Documented allergy to gadolinium
Current LVEF \<45%
STEMI within 3-7 days post MI, or Acute coronary syndrome/NSTEMI with with symptoms or signs of acute myocardial ischemia within the last 12 to 24 hours prior to the research procedure, as outlined in ACC/AHA guidelines.
Acute coronary syndrome (defined by ACC/AHA guidelines, including MI) within 3 months of entry. Patients who have had an MI or other event within the 6 months prior to entry unless an echo measurement performed after the event confirms a LVEF ≥45%.
Primary valvular heart disease (moderate regurgitation or\>mild stenosis), primary cardiomyopathies (hypertrophic, infiltrative or restrictive), constrictive pericarditis, high-output heart failure, and right ventricular myopathies)
Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support or current acute decompensated HF requiring therapy including due to trauma, infection.
Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) \<10 g/dl, or body mass index (BMI) \> 40 kg/m2.
Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP \>150 mmHg and \<180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs.
Prior or planned percutaneous coronary intervention or coronary artery bypass grafting for obstructive coronary atherosclerosis
Non-cardiac illness with a life expectancy \< four years
Unable to give informed consent
Contraindications to CMRI, such as internal cardiac defibrillator, untreatable claustrophobia or known angioedema
Contraindications to adenosine or regadenoson including severe COPD and asthma.
Obstructive stenoses (≥50% luminal diameter stenosis assessed visually at the time of research CTA) will be excluded from further analyses. Subjects with obstructive or borderline obstructive coronary CTA stenoses will be referred to their clinicians for further clinical care and clinical decision making. End stage renal or liver disease
What this trial measures
- Cardiovascular (CV) eventsup to 30 years