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

Study Design

Observational model case-only
Time perspective prospective
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.
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.

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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Menssana Research, Inc..