Trial record 6 of 52 for:    Open Studies | "heart transplantation"

Heartsbreath Test for Heart Transplant Rejection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Menssana Research, Inc..
Recruitment status was  Recruiting
Sponsor:
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
  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 April 17, 2014