Clinical trials: Heart Transplant Rejection
Heart Transplant Rejection
Surveillance HeartCare® Outcomes Registry
This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.
- Trial name
- SHORE (NCT03695601)
- Testing
- Standard of Care
- Where
- 67 sites in United States
- Volunteers
- 2,743 people
- Sponsor
- CareDx
Heart Transplant Failure and Rejection
A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy
This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site.
- Trial name
- ACES-EMB (NCT06414603)
- Testing
- The Prospera™ Test
- Where
- 16 sites in United States
- Volunteers
- 250 people
- Sponsor
- Natera, Inc.
Heart Transplant Rejection
Prospera Test Evaluation in Cardiac Transplant (ProTECT)
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart…
- Trial name
- ProTECT (NCT05205551)
- Where
- United States
- Volunteers
- 411 people
- Sponsor
- Natera, Inc.
Cardiac Transplant Failure, Cardiac Transplant Rejection
Utility of Donor-Derived Cell Free DNA in Association With Gene Expression Profiling
Plasma donor-derived cell-free DNA (dd-cfDNA) is measured as a % of the total plasma cfDNA in association with the measurement of AlloMap, a non-invasive gene expression test to aid in heart transplant management.
- Conditions
- Cardiac Transplant Failure, Cardiac Transplant Rejection, Heart Diseases
- Trial name
- D-OAR (NCT02178943)
- Where
- 28 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- CareDx
Heart Transplant Failure and Rejection
Donor-Derived Cell-free DNA to DETect REjection in Cardiac Transplantation
The study objective is to demonstrate that rejection surveillance of heart transplant recipients with Prospera dd-cfDNA is non-inferior to rejection surveillance with endomyocardial biopsy and histology in the first…
- Trial name
- DETECT (NCT05081739)
- Testing
- Prospera Transplant Assessment, Endomyocardial biopsy
- Sponsor
- Natera, Inc.
Acute Rejection of Cardiac Transplant
Non-invasive Test for Acute Rejection Identification in Heart Transplanted Patients
Aim of the study is to test INNOGRAFT Heart Suite in a clinical setting, using a previously collected set of plasma samples from patients who underwent heart transplant and routinely or symptoms-based surveillance during the…
- Trial name
- INNOGRAFTRS001 (NCT04274712)
- Testing
- INNOGRAFT Heart Suite
- Where
- Italy
- Volunteers
- 72 people
- Sponsor
- Myway Gentics Srl
Cardiac Transplant Failure, Cardiac Transplant Rejection
Outcomes AlloMap Registry: the Long-term Management and Outcomes of Heart Transplant Recipients With AlloMap Testing
The objective of this registry is to observe short and long term clinical outcomes in heart transplant recipients who receive regular AlloMap testing as part of allograft rejection surveillance.
- Conditions
- Cardiac Transplant Failure, Cardiac Transplant Rejection, Heart Diseases
- Trial name
- OAR (NCT01833195)
- Where
- 36 sites in United States
- Volunteers
- 2,444 people, healthy volunteers welcome
- Sponsor
- CareDx
Heart Transplant Rejection
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).
- Trial name
- Heartsbreath (NCT01397812)
- Testing
- BreathScanner 1.0, BreathLink
- Where
- 5 sites in United States
- Volunteers
- 1,200 people
- Sponsor
- Menssana Research, Inc.