Heartsbreath Test for Heart Transplant Rejection
This study is currently recruiting participants.
Verified October 2011 by Menssana Research, Inc.
Sponsor:
Menssana Research, Inc.
Collaborator:
Information provided by (Responsible Party):
Menssana Research, Inc.
ClinicalTrials.gov Identifier:
NCT01397812
First received: June 23, 2011
Last updated: October 27, 2011
Last verified: October 2011
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Purpose
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 |
|---|
|
Heart Transplant Rejection |
| 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: | June 2013 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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.
Eligibility| 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
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397812
Locations
| United States, California | |
| Cedars-Sinai Medical Center | Not yet recruiting |
| Beverly Hills, California, United States, 90211 | |
| Contact: Jon A. Kobashigawa, MD 310-238-8300 KobashigawaJ@cshs.org | |
| Principal Investigator: Jon A Kobashigawa, MD | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305-5406 | |
| Contact: Hannah A Valantine, MD, MRCP, FACC 650.736.1483 hvalantine@stanford.edu | |
| Contact: Helen I Luikart 650-724-2883 luikart@stanford.edu | |
| Principal Investigator: Hannah A. Valantine, MD, MRCP, FACC | |
| United States, New Jersey | |
| Newark Beth Israel Medical Center | Active, not recruiting |
| Newark, New Jersey, United States, 07112 | |
| United States, New York | |
| Columbia Presbyterian Medical Center | Active, not recruiting |
| New York, New York, United States, 10032 | |
| United States, Pennsylvania | |
| Hahnemann University Hospital and the Drexel University College of Medicine | Active, not recruiting |
| Philadelphia, Pennsylvania, United States, 19102 | |
Sponsors and Collaborators
Menssana Research, Inc.
Investigators
| Principal Investigator: | Michael Phillips, MD, FACP | Menssana Research, Inc. |
More Information
No publications provided
| Responsible Party: | Menssana Research, Inc. |
| ClinicalTrials.gov Identifier: | NCT01397812 History of Changes |
| Other Study ID Numbers: | MR-2011-03, 2R44HL059715-04A1 |
| Study First Received: | June 23, 2011 |
| Last Updated: | October 27, 2011 |
| 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 |
ClinicalTrials.gov processed this record on May 16, 2013