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Scientists hunt for simple blood test to predict heart rejection

NCT ID NCT00042614

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 16 times

Summary

This study aims to find substances in blood or urine that can signal when a transplanted heart is being rejected. By analyzing samples from 188 heart transplant patients and healthy volunteers, researchers hope to develop a simple test for early detection. The goal is to catch rejection sooner and improve treatment, potentially preventing long-term damage.

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

188 people

The number who actually took part.

Started

Apr 2003

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who have had heart transplants, Patients Awaiting Heart Transplant, and Controls screened to obtain. Controls matched to patients for age, gender and race.@@@

Ages

18 to 100 years

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 Transplant Patients: 1. Adult heart transplant center generally accepts patients within the physiologic age range of 12 to 65 years old, however, for our study heart transplant patients must be 18 years of age or above. 2. Indication for cardiac transplantation as outlined by the 24th Bethesda Conference on Cardiac Transplantation. These are as follows: * Peak VO(2) less than 10 ml/kg per minute or less than 50% of maximal predicted VO(2) with achievement of anaerobic metabolism. * Severe cardiac ischemia consistently limiting routine activity not amenable to surgical or percutaneous revascularization. * Recurrent symptomatic ventricular arrhythmias refractory to all accepted therapeutic modalities. EXCLUSION CRITERIA - for Transplant Patients: Adult heart transplant centers exclude infants, toddlers, and children with a physiologic age less than 12, and adults with advanced physiologic age (less than 65), however, for our study we will exclude heart transplant patients less than 18 years of age. The final decision to exclude a candidate from cardiac transplantation will be made by the hospital's heart transplant committee. The committee uses, as a guideline, the criteria outlined in the 24th Bethesda conference. INCLUSION CRITERIA - for Control Subjects: Any healthy normal man or women who is the appropriate age and gender for matching to a transplant patient. EXCLUSION CRITERIA - For Control Subjects: 1. EKG with evidence of clinically relevant heart disease. 2. Echocardiogram with evidence of clinically relevant heart disease. 3. Any disease process that is not well controlled by medications. 4. Total tobacco use for greater than one month over the last 5 years. 5. Symptoms of coronary or cardiac insufficiency. 6. More than one major risk factor for coronary artery disease excluding gender or age. 7. Confirmed intrauterine pregnancy in women.

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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.

Contacts and locations

Locations

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

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