Scientists hunt for simple blood test to predict heart rejection
NCT ID NCT00042614
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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188 people
The number who actually took part.
- Started
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Apr 2003
- Lead sponsor
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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
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18 to 100 years
- 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 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
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Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Thymus cells may teach a new heart to be left alone
- Can a new care pathway speed up advanced heart failure decisions?
- Can a transition program keep young heart transplant patients on track?
- New study aims to spot heart transplant rejection without a biopsy
- Simple saltwater solution may shield kidneys after heart transplant
- Blood test may replace painful heart biopsies for transplant patients