Validation of Heartsbreath Test for Heart Transplant Rejection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Transplant Rejection
- Sponsor
- Menssana Research, Inc.
- Enrollment
- 1200
- Locations
- 5
- Primary Endpoint
- 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.
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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).