Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Heartsbreath Test for Heart Transplant Rejection

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Menssana Research, Inc. Identifier:
First received: June 23, 2011
Last updated: May 15, 2014
Last verified: May 2014

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).

Condition Intervention
Heart Transplant Rejection
Device: BreathScanner 1.0
Device: BreathLink

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of Heartsbreath Test for Heart Transplant Rejection

Resource links provided by NLM:

Further study details as provided by Menssana Research, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).

Estimated Enrollment: 1200
Study Start Date: December 2010
Estimated Study Completion Date: September 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions

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.

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01397812

United States, California
Cedars-Sinai Medical Center
Beverly Hills, California, United States, 90211
Stanford University School of Medicine
Stanford, California, United States, 94305-5406
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Hahnemann University Hospital and the Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Menssana Research, Inc.
Principal Investigator: Michael Phillips, MD, FACP Menssana Research, Inc.
  More Information

No publications provided

Responsible Party: Menssana Research, Inc. Identifier: NCT01397812     History of Changes
Other Study ID Numbers: MR-2011-03, 2R44HL059715-04A1
Study First Received: June 23, 2011
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Menssana Research, Inc.:
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 processed this record on March 02, 2015