NCT01397812

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2011

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

3 years

First QC Date

June 23, 2011

Last Update Submit

April 6, 2015

Conditions

Heart Transplant Rejection

Keywords

Rejection of the Heart TransplantHeart Transplant Rejection, an immune-mediated allograft injuryNon-cellular or humoral rejection in cardiac transplant recipientsRight ventricular endomyocardial biopsy to detect Heart transplant rejection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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. Subjects will provide breath samples for the Heartsbreath test using the BreathScanner 1.0. Optionally subjects will provide breath samples using the BreathLink point of care system.

Device: BreathScanner 1.0Device: BreathLink

Interventions

BreathScanner 1.0DEVICE

For the HeartsBreath test, breath is collected using BreathScanner 1.0 and sent to central laboratory for analysis for markers of transplant rejection.

1
BreathLinkDEVICE

The BreathLink point-of-care system detects and quantifies the breath VOC's determined to be biomarkers during the development of the Heartsbreath test.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subject is the recipient of a heart transplant within the previous 12 months and is scheduled for a routine endomyocardial biopsy

You may qualify if:

  • 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

You may not qualify if:

  • Evidence of acute intercurrent disease other than rejection reaction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cedars-Sinai Medical Center

Beverly Hills, California, 90211, United States

Location

Stanford University School of Medicine

Stanford, California, 94305-5406, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

Hahnemann University Hospital and the Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Study Officials

  • Michael Phillips, MD, FACP

    Menssana Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2011

First Posted

July 20, 2011

Study Start

December 1, 2010

Primary Completion

December 1, 2013

Study Completion

September 1, 2016

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(5)