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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44HL059715-04A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BreathScanner 1.0 | Device | For the HeartsBreath test, breath is collected using BreathScanner 1.0 and sent to central laboratory for analysis for markers of transplant rejection. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subject is the recipient of a heart transplant within the previous 12 months and is scheduled for a routine endomyocardial biopsy
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| Name | Affiliation | Role |
|---|---|---|
| Michael Phillips, MD, FACP | Menssana Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Beverly Hills | California | 90211 | United States | ||
| Stanford University School of Medicine |
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| BreathLink | Device | The BreathLink point-of-care system detects and quantifies the breath VOC's determined to be biomarkers during the development of the Heartsbreath test. |
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| Stanford |
| California |
| 94305-5406 |
| United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Columbia Presbyterian Medical Center | New York | New York | 10032 | United States |
| Hahnemann University Hospital and the Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | United States |