Status:
UNKNOWN
Heartsbreath Test for Heart Transplant Rejection
Lead Sponsor:
Menssana Research, Inc.
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Transplant Rejection
Eligibility:
All Genders
18+ years
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. Th...
Eligibility Criteria
Inclusion
- 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
- Evidence of acute intercurrent disease other than rejection reaction
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT01397812
Start Date
December 1 2010
End Date
September 1 2016
Last Update
April 7 2015
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars-Sinai Medical Center
Beverly Hills, California, United States, 90211
2
Stanford University School of Medicine
Stanford, California, United States, 94305-5406
3
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
4
Columbia Presbyterian Medical Center
New York, New York, United States, 10032