Heart Transplant RejectionHeartsbreathNCT01397812
Heartsbreath Test for Heart Transplant Rejection
An observational study of Heart Transplant Rejection, run by Menssana Research, Inc. at 5 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant Rejection
- What is being tested?
- BreathScanner 1.0 and BreathLink
- Type of treatment
- Medical device
- How many people
- 1,200 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2010to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject is the recipient of a heart transplant within the previous 12 months and is scheduled for a routine endomyocardial biopsy
Who may be able to join
- 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
Who cannot join
- Evidence of acute intercurrent disease other than rejection reaction
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cedars-Sinai Medical Center
Beverly Hills, California, 90211
Columbia Presbyterian Medical Center
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Hahnemann University Hospital and the Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Stanford University School of Medicine
Stanford, California, 94305-5406
About this study
Official title: Validation of Heartsbreath Test for Heart Transplant Rejection
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).
Read the 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.
- Conditions
- Heart Transplant Rejection
- Being tested
- BreathScanner 1.0, BreathLink
- Keywords
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BreathScanner 1.0; Device: BreathLink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 60 days after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menssana Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michael Phillips, MD, FACP, Principal investigator, Menssana Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397812
- Sponsor's protocol ID
- MR-2011-03
- Other IDs
- 2R44HL059715-04A1
- Acronym
- Heartsbreath
- Status last verified
- Apr 2015
- First submitted
- 23 Jun 2011
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Heartsbreath Test for Heart Transplant Rejection
- ClinicalTrials.gov ID
- NCT01397812
- Acronym / sponsor ID
- Heartsbreath / MR-2011-03
- Conditions
- Heart Transplant Rejection
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Menssana Research, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Sep 2016 (estimated)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: BreathScanner 1.0, Device: BreathLinkSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject is the recipient of a heart transplant within the previous 12 months and is scheduled for a routine endomyocardial biopsy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Evidence of acute intercurrent disease other than rejection reaction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreathScanner 1.0For the HeartsBreath test, breath is collected using BreathScanner 1.0 and sent to central laboratory for analysis for markers of transplant rejection. | Device | 1 |
| BreathLinkThe BreathLink point-of-care system detects and quantifies the breath VOC's determined to be biomarkers during the development of the Heartsbreath test. | Device | 1 |
Primary outcome
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
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Phillips, MD, FACP principal investigator
Menssana Research, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant Rejection, run by Menssana Research, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.