Heartsbreath Test for Heart Transplant Rejection

Heart Transplant Rejection Clinical Trial

— Heartsbreath  

Official title:

Validation of Heartsbreath Test for Heart Transplant Rejection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01397812
• Other study ID #: MR-2011-03
• Secondary ID: 2R44HL059715-04A
• Status: Active, not recruiting
• Phase: N/A
• First received: June 23, 2011
• Last updated: April 6, 2015
• Start date: December 2010
• Est. completion date: September 2016

Study information

• Verified date: April 2015
• Source: Menssana Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: September 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Transplant Rejection

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Beverly Hills	California
United States	Columbia Presbyterian Medical Center	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Hahnemann University Hospital and the Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Menssana Research, Inc.	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).	60 days after completion	No