Heartsbreath Test for Heart Transplant Rejection
This trial is active, not recruiting.
|Condition||heart transplant rejection|
|Treatments||breathscanner 1.0, breathlink|
|Sponsor||Menssana Research, Inc.|
|Collaborator||National Heart, Lung, and Blood Institute (NHLBI)|
|Start date||December 2010|
|End date||December 2013|
|Trial size||1200 participants|
|Trial identifier||NCT01397812, 2R44HL059715-04A1, MR-2011-03|
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).
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Beverly Hills, CA||Cedars-Sinai Medical Center||no longer recruiting|
|Stanford, CA||Stanford University School of Medicine||no longer recruiting|
|Newark, NJ||Newark Beth Israel Medical Center||no longer recruiting|
|New York, NY||Columbia Presbyterian Medical Center||no longer recruiting|
|Philadelphia, PA||Hahnemann University Hospital and the Drexel University College of Medicine||no longer recruiting|
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
Male or female participants at least 18 years old.
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
|Official title||Validation of Heartsbreath Test for Heart Transplant Rejection|
|Principal investigator||Michael Phillips, MD, FACP|
|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.|
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