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New study aims to unlock secrets of heart transplant failure

NCT ID NCT03102125

Knowledge-focused Sponsor: Paul Kim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at why some transplanted hearts stop working well over time. Researchers will use heart MRI scans and advanced cell analysis to find early signs of trouble in 376 heart transplant patients. The goal is to better understand the causes of graft dysfunction so doctors can improve long-term survival for transplant recipients.

What this could mean

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

Active substance
Regadenoson (Lexiscan)
What this could lead to
If successful, this could help doctors detect early signs of heart transplant failure and improve how long transplanted hearts last.
What could go wrong
This is an observational study, not testing a new treatment. It may not lead to direct changes in patient care, and results may take years to apply.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 376 people

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

Started

Oct 2019

Expected to finish

Jan 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.

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: * Age greater than or equal to 18 years old. * At least three months status post heart transplantation. Exclusion Criteria: * Biopsy proven acute rejection episode in the past 3 months. * Patients with symptoms or signs of acute myocardial ischemia or recent acute coronary syndrome in the past 3 months. * Uncontrolled obstructive ventilatory disease including asthma and COPD. * History of generalized tonic-clonic seizures. * Second or third degree AV nodal block. * Sinus node dysfunction. * Contraindications to MRI including cardiovascular implantable electronic devices. * Renal dysfunction with an estimated GFR less than 30 mL/min/1.73m2. * Prior adverse reaction to either regadenoson or gadolinium contrast. Prior adverse reaction to adenosine or dipyridamole will be assessed on a case-by-case basis. * Systolic blood pressure greater than 180 or less than 85 mmHg. * Diastolic blood pressure greater than 120 or less than 40 mmHg. * Resting heart rate greater than 120 or less than 45 beats per minute. - Severe claustrophobia.

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Conditions

The condition(s) this trial relates to.

Rejection, Psychology transplant rejection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart transplant failure and rejection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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.

    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

  • UC San Diego

    RECRUITING

    La Jolla, California, 92037, United States

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