Clinical trials: Heart Transplant Rejection
Graft Rejection, Kidney Failure
Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal…
- Trial name
- NCT00369382
- Testing
- cyclosporine or tacrolimus, sirolimus
- Where
- 23 sites in United States, Australia and 5 more
- Volunteers
- 121 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Heart Transplantation
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.
This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and steroids, in patients receiving a heart transplant.
- Trial name
- NCT02091414
- Testing
- mycophenolate mofetil (MMF), cyclosporine A (CsA), corticosteroids
- Where
- 3 sites in China
- Volunteers
- 36 people
- Sponsor
- Hoffmann-La Roche
Graft Rejection, Heart Disease
Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY
The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II Study is designed to provide independent evidence of the clinical performance of the non-invasive AlloMap test.
- Trial name
- CARGOII (NCT00761787)
- Where
- 17 sites in United States, Austria and 9 more
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- XDx
Heart Transplantation
A Study of Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants
This study will evaluate the efficacy and safety of intravenous daclizumab in combination with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart transplant, and at risk of impaired kidney function.
- Trial name
- NCT02554955
- Testing
- Daclizumab, Mycophenolate mofetil, Silrolimus
- Where
- 14 sites in Spain
- Volunteers
- 36 people
- Sponsor
- Hoffmann-La Roche
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.
Heart Diseases, Heart Transplantation
Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens
The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.
- Trial name
- NCT00157014
- Testing
- Tacrolimus, Cyclosporine, Mycophenolate mofetil
- Where
- 13 sites in United States, Canada
- Volunteers
- 111 people
- Sponsor
- Astellas Pharma Inc
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.
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
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
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.
Graft Rejection
Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection that can happen after heart transplantation. It is usually used in combination with other immunosuppressive drugs such as cyclosporine.
- Trial name
- NCT00097968
- Testing
- everolimus
- Where
- 6 sites in United States
- Sponsor
- Novartis Pharmaceuticals
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 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.
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
Renal Transplant Rejection
Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids
The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept®…
- Trial name
- IBERICA (NCT01324934)
- Testing
- ATG-Fresenius S
- Where
- 10 sites in Portugal, Spain
- Volunteers
- 40 people
- Sponsor
- Neovii Biotech
Coronary Heart Disease
Post-marketing Study to Collect Safety Data in Heart Transplant Patients Receiving Everolimus
The purpose of this observational protocol is to evaluate the use of everolimus in routine clinical practice for heart transplants. Primary outcome measures: incidence of acute rejection episodes Secondary outcomes: safety
- Trial name
- NCT00134940
- Where
- 6 sites in Austria, Germany
- Volunteers
- 100 people
- Sponsor
- Novartis
Renal Transplant
24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients
The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant…
- Trial name
- EVITA (NCT01169701)
- Testing
- Everolimus, Tacrolimus, Mycophenolic acid (MPA)
- Where
- 9 sites in Spain
- Volunteers
- 71 people
- Sponsor
- Novartis Pharmaceuticals
Heart Transplantation
SCHEDULE Follow Up Visit 5-7 yr
The major aim of this extension study was to evaluate the long-term effect (i.e. 5 to 7 years) of early initiation of everolimus and early elimination of CsA compared to standard immunosuppressive regimen including CsA on primary…
- Trial name
- CRAD001ANO05 (NCT02864706)
- Testing
- Everolimus, Cyclosporine, Mycophenolate mofetil
- Where
- 6 sites in Denmark, Norway and 1 more
- Volunteers
- 95 people
- Sponsor
- Novartis Pharmaceuticals
Graft Rejection, Heart Diseases
IMAGE: A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection
This study is designed to evaluate the safety and efficacy of a leukocyte gene expression profiling method in the monitoring of asymptomatic heart transplant patients for acute rejection.
- Trial name
- NCT00351559
- Testing
- AlloMap molecular expression testing, Right ventricular endomyocardial biopsy
- Where
- 13 sites in United States
- Volunteers
- 629 people
- Sponsor
- XDx
Graft Rejection
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
This trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients.
- Trial name
- NCT00300274
- Testing
- everolimus, mycophenolate mofetil, cyclosporine
- Where
- 64 sites in United States, Argentina and 13 more
- Volunteers
- 721 people
- Sponsor
- Novartis Pharmaceuticals