Heartsbreath Test for Heart Transplant Rejection (Heartsbreath)

Validation of Heartsbreath Test for Heart Transplant Rejection

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).

Study Overview

• Status: Unknown
• Conditions: Heart Transplant Rejection
• Intervention / Treatment: Device: BreathScanner 1.0; Device: BreathLink

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 Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Cedars-Sinai Medical Center
    • Stanford, California, United States, 94305-5406
      • Stanford University School of Medicine
  • New Jersey
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia Presbyterian Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Hahnemann University Hospital and the Drexel University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subject is the recipient of a heart transplant within the previous 12 months and is scheduled for a routine endomyocardial biopsy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; 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.	Device: 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.; Device: BreathLink; The BreathLink point-of-care system detects and quantifies the breath VOC's determined to be biomarkers during the development of the Heartsbreath test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	60 days after completion

Collaborators and Investigators

• Sponsor: Menssana Research, Inc.
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ANTICIPATED): September 1, 2016

Study Registration Dates

• First Submitted: June 23, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (ESTIMATE): July 20, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 7, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Rejection of the Heart Transplant; Heart Transplant Rejection, an immune-mediated allograft injury; Non-cellular or humoral rejection in cardiac transplant recipients; Right ventricular endomyocardial biopsy to detect Heart transplant rejection
• Other Study ID Numbers: MR-2011-03; 2R44HL059715-04A1 (NIH)