Heartsbreath Test for Heart Transplant Rejection (Heartsbreath)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01397812|
Recruitment Status : Unknown
Verified April 2015 by Menssana Research, Inc..
Recruitment status was: Active, not recruiting
First Posted : July 20, 2011
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment|
|Heart Transplant Rejection||Device: BreathScanner 1.0 Device: BreathLink|
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Validation of Heartsbreath Test for Heart Transplant Rejection|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||September 2016|
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.
The BreathLink point-of-care system detects and quantifies the breath VOC's determined to be biomarkers during the development of the Heartsbreath test.
- 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 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|