Heartsbreath Test for Heart Transplant Rejection (NCT01397812) | Clinical Trial Compass
UnknownNot Applicable
Heartsbreath Test for Heart Transplant Rejection
United States1,200 participantsStarted 2010-12
Plain-language summary
The purpose of this study is to demonstrate and validate a breath test for detection of biomarkers of heart transplant rejection (Grade 2R heart transplant).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is willing and able to cooperate with study, understand the scope of the study, and gives signed informed consent to participate.
* Subject is the recipient of a heart transplant within the previous 12 months
* Subject is scheduled for a routine endomyocardial biopsy
* Subject is 18 years or older
Exclusion Criteria:
* Evidence of acute intercurrent disease other than rejection reaction
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is testing the Heartsbreath breath test as a way to detect heart transplant rejection without a biopsy, could you explain how the breath test compares in accuracy to the standard endomyocardial biopsy that I'm currently being monitored with?
2The recruitment status for this trial is listed as unknown — do you know whether this study is still actively enrolling patients, and if not, are there similar studies evaluating non-invasive rejection monitoring that I might be eligible for?
3If the breath test turns out to be less sensitive than the biopsy, what would that mean for my safety — could a rejection episode be missed if this test were used instead of the standard approach?
4Since this trial is described as Phase NA and is measuring sensitivity and specificity rather than treatment outcomes, does that mean it's primarily a diagnostic research study, and that my actual rejection monitoring and treatment would still follow the standard care pathway?
5How would participating in this trial fit into my existing transplant follow-up schedule — would I still be required to undergo the regular endomyocardial biopsies on top of providing breath samples?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To measure the sensitivity and specificity of the breath test as compared to the primary right ventricular endomyocardial biopsy for the development of an intrinsically safe, painless, and non-invasive detection technique.