Heartsbreath Test for Heart Transplant Rejection

Menssana Research, Inc.1,200 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

1,200

Conditions

Heart Transplant Rejection

Interventions

BreathScanner 1.0DEVICE

For the HeartsBreath test, breath is collected using BreathScanner 1.0 and sent to central laboratory for analysis for markers of transplant rejection.

BreathLinkDEVICE

The BreathLink point-of-care system detects and quantifies the breath VOC's determined to be biomarkers during the development of the Heartsbreath test.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Cedars-Sinai Medical Center

Beverly Hills, California, United States

Stanford University School of Medicine

Stanford, California, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Columbia Presbyterian Medical Center

New York, New York, United States

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.

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).

Time frame: 60 days after completion

Data from ClinicalTrials.gov

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