Could tiny heart vessels hold the key to a common form of heart failure?
NCT ID NCT02582021
First seen Aug 21, 2026 · Last updated Aug 21, 2026
Summary
This study investigates whether coronary microvascular dysfunction (CMD) — problems with the tiny blood vessels in the heart — contributes to heart failure with preserved ejection fraction (HFpEF), a condition where the heart pumps normally but is too stiff to fill properly. Researchers will follow women with chest pain and no major blockages, as well as men and women hospitalized with HFpEF, using coronary angiography and reactivity tests to examine vessel function. The goal is to understand how CMD might lead to heart failure, which could improve diagnosis and treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Coronary angiography and coronary reactivity testing (procedures to examine heart blood vessels and their function)
- What this could lead to
- If successful, this could clarify how small heart vessel problems contribute to heart failure, potentially guiding new prevention and treatment strategies.
- What could go wrong
- This is an observational study, so it cannot prove cause and effect. The findings may not apply to all patients, and the procedures carry small risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 220 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2015
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
A group of symptomatic women undergoing coronary angiography (n=120) for suspected ischemia and no obstructive CAD, defined as ≥50% luminal diameter stenosis in ≥1 epicardial artery, will be recruited. A group of women and men hospitalized for HFpEF, defined by the ESC criteria (n=100) who have not yet undergone coronary angiography will also be recruited for the study.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: For the new cohort n=120 women undergoing coronary angiography: * Symptomatic angina or anginal equivalent * Age ≥ 18 * Participant is willing to give written informed consent For the cohort n=100 women and men hospitalized for HFpEF (defined by ESC guidelines): * 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 Criteria: For the new cohort n=120 women undergoing invasive coronary angiography: * 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 For the new cohort n=100 women and men hospitalized for HFpEF: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars-Sinai Women's Heart Center
RECRUITINGLos Angeles, California, 90048, United States
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