Heartsbreath Test for Heart Transplant Rejection

• Register: ClinicalTrials.gov
• Last refreshed on: 20 April 2015
• Main ID: NCT01397812
• Date of registration: 23/06/2011
• Prospective Registration: No
• Primary sponsor: Menssana Research, Inc.
• Public title: Heartsbreath Test for Heart Transplant Rejection Heartsbreath
• Scientific title: Validation of Heartsbreath Test for Heart Transplant Rejection
• Date of first enrolment: December 2010
• Target sample size: 1200
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01397812
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Michael Phillips, MD, FACP
• Affiliation: Menssana Research, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Heart Transplant Rejection

Intervention(s)

Device: BreathLink

Device: BreathScanner 1.0

Primary Outcome(s)

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]

Secondary ID(s)

MR-2011-03

2R44HL059715-04A1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)