Can tiny heart vessel damage predict heart failure?

NCT ID NCT03876223

What the study statuses mean

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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.
Paused
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 Results may not be published yet.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)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This study looks at how small vessel disease—narrowing of the tiny arteries in the heart—might contribute to a condition called pre-heart failure with preserved ejection fraction (pre-HFpEF), where the heart muscle doesn't relax properly despite pumping normally. Researchers will follow 180 people with symptoms of reduced blood flow but no major blockages, using cardiac MRI and pressure measurements to track changes over a year. The goal is to better understand the link and find ways to prevent full heart failure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cardiac MRI with contrast agent and invasive pressure-volume measurements
What this could lead to
If successful, this could identify early markers and potential targets to prevent heart failure with preserved ejection fraction in people with small vessel disease.
What could go wrong
This is an observational study, so it won't test a treatment directly. The results may not lead to immediate prevention strategies, and the invasive procedures carry some risks.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 180 people

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

Started

Jul 2019

Expected to finish

Feb 2027

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

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.

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: 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

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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.

  1. The places running it

    2 sites. 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.

    Open the record ↗

  3. 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

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

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