UnknownNot Applicable

Heartsbreath Test for Heart Transplant Rejection

United States1,200 participantsStarted 2010-12

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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.

Timeframe: 60 days after completion

Trial details

NCT IDNCT01397812

SponsorMenssana Research, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Heart Transplant Rejection trials