Could tiny heart vessels hold the key to a common form of heart failure?

NCT ID NCT02582021

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2015

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Cedars-Sinai Women's Heart Center

    RECRUITING

    Los Angeles, California, 90048, United States

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