Heartsbreath Test for Heart Transplant Rejection

Menssana Research

Status: Unknown

Conditions: Heart Transplant Rejection

Treatments: Device: BreathScanner 1.0; Device: BreathLink

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT01397812

2R44HL059715-04A1 (U.S. NIH Grant/Contract)

MR-2011-03

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,200 participants in 1 patient group

1

Description:

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.

Treatment:

Device: BreathScanner 1.0

Device: BreathLink