Heartsbreath Test for Heart Transplant Rejection

• Conditions: Heart Transplant Rejection
• Interventions: Device: BreathScanner 1.0; Device: BreathLink

• Registration Number: NCT01397812
• Lead Sponsor: Menssana Research, Inc.

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Primary Completion: 2013-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	BreathLink	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.
1	BreathScanner 1.0	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.

Primary Outcome Measures

Name	Time	Method
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.	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).

Trial Locations

Locations (5)

Hahnemann University Hospital and the Drexel University College of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

Cedars-Sinai Medical Center; 🇺🇸 Beverly Hills, California, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Columbia Presbyterian Medical Center; 🇺🇸 New York, New York, United States

Newark Beth Israel Medical Center; 🇺🇸 Newark, New Jersey, United States