Heartsbreath Test for Heart Transplant Rejection
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).
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Validation of Heartsbreath Test for Heart Transplant Rejection|
- 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. [ Time Frame: 60 days after completion ] [ Designated as safety issue: No ]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).
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||September 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Subjects will comprise of patients who are the recipients of a heart transplant within the previous 12 months and are scheduled for a routine endomyocardial biopsy.
Subjects will provide breath samples for the Heartsbreath test using the BreathScanner 1.0. Optionally subjects will provide breath samples using the BreathLink point of care system.
Device: BreathScanner 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.Device: BreathLink
The BreathLink point-of-care system detects and quantifies the breath VOC's determined to be biomarkers during the development of the Heartsbreath test.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397812
|United States, California|
|Cedars-Sinai Medical Center|
|Beverly Hills, California, United States, 90211|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305-5406|
|United States, New Jersey|
|Newark Beth Israel Medical Center|
|Newark, New Jersey, United States, 07112|
|United States, New York|
|Columbia Presbyterian Medical Center|
|New York, New York, United States, 10032|
|United States, Pennsylvania|
|Hahnemann University Hospital and the Drexel University College of Medicine|
|Philadelphia, Pennsylvania, United States, 19102|
|Principal Investigator:||Michael Phillips, MD, FACP||Menssana Research, Inc.|