Heart Transplant Rejection
Conditions
Keywords
Rejection of the Heart Transplant, Heart Transplant Rejection, an immune-mediated allograft injury, Non-cellular or humoral rejection in cardiac transplant recipients, Right ventricular endomyocardial biopsy to detect Heart transplant rejection
Brief 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).
Detailed description
This is a 36 month multi-center, open label, unblinded and blinded study on subjects have had a heart transplant within the previous 12 months and are scheduled to undergo an endomyocardial biopsy. The breath test will be performed to identify and validate the predicative algorithms that identify breath biomarkers for heart transplant rejection.
Interventions
DEVICEBreathScanner 1.0
For the HeartsBreath test, breath is collected using BreathScanner 1.0 and sent to central laboratory for analysis for markers of transplant rejection.
DEVICEBreathLink
The BreathLink point-of-care system detects and quantifies the breath VOC's determined to be biomarkers during the development of the Heartsbreath test.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Menssana Research, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 60 days after completion | The current gold standard for heart transplant rejection diagnosis is a series of endomyocardial biopsies during the first twelve months after operation. This procedure is invasive, painful, and potentially hazardous. The Heartsbreath test is an intrinsically safe, painless, and non-invasive breath test for heart transplant rejection that employs volatile biomarkers of oxidative stress. The Food & Drug Administration (FDA) approved the Heartsbreath test for clinical use with a Humanitarian Device Exemption (HDE). |
Countries
United States
Outcome results
None listed