Clinical trials: Rejection Heart Transplant
Heart Transplant Rejection
A New Biomarker for the Non-invasive Diagnosis of Rejection After Heart Transplantation
This study is a prospective, observational multi-center cohort study. The study will consist of patients undergoing heart transplantation.
- Trial name
- BIODRAFT (NCT03477383)
- Testing
- donor-derived cell-free DNA (dd-cfDNA)
- Where
- 4 sites in Sweden
- Volunteers
- 134 people
- Sponsor
- Vastra Gotaland Region
Cardiac Transplant Rejection, Lung Transplant Rejection
Genome Transplant Dynamics: Non-invasive Sequencing-based Diagnosis of Rejection
The purpose of this study is to determine whether shotgun sequencing technology, which can be used to detect donor DNA in recipient plasma, can be used as a rapid, accurate, non-invasive method to detect Acute Cellular Rejection…
- Trial name
- GTD (NCT01985412)
- Where
- 2 sites in United States
- Volunteers
- 65 people
- Sponsor
- Stanford University
Cardiac Graft
Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging
Acute heart allograft rejection is a common complication after orthotopic heart transplantation. Primary objective of this study is to assess cardiac MRI as a tool for acute heart graft rejection screening, by detecting changes…
- Trial name
- DRAGON (NCT02400840)
- Testing
- cardiac MRI, gadobenic acid intravenous injection 0.2 ml/kg
- Where
- France
- Sponsor
- University Hospital, Rouen
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
Acute Graft Rejection
Magnetic Resonance Elastography of Cardiac Transplant Rejection
Magnetic Resonance Elastography (MRE) for cardiac transplant patients.
- Trial name
- NCT02266914
- Testing
- Magnetic Resonance Elastography driver
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Ohio State University
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 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.
Allosensitization, Heart Transplant Failure and Rejection
Study of Daratumumab for Decreasing Circulating Antibodies in Sensitized Patients Awaiting Heart Transplantation
The purpose of this study is to test whether daratumumab, a drug that eliminates antibody-producing plasma cells, can effectively lower the level of preformed antibodies in patients awaiting heart transplantation.
- Trial name
- NCT04088903
- Testing
- Daratumumab
- Sponsor
- Ronald Witteles
Heart Transplant
Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients
Injury of transplant tissue by a transplant recipient's immune system continues to be the leading cause of graft rejection and recipient death.
- Trial name
- NCT00466804
- Testing
- Heart transplant
- Where
- 12 sites in United States
- Volunteers
- 263 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cardiac Allograft Vasculopathy, Chronic Rejection of Cardiac Transplant
Heart Failure After Heart Transplantation Due to Chronic Rejection
This study will investigate the prevalence of allograft vasculopathy and unexplained graft dysfunction during long-term follow-up after heart transplantation. Risk factors as well diagnostic approaches will be investigated.
- Conditions
- Cardiac Allograft Vasculopathy, Chronic Rejection of Cardiac Transplant, Graft Dysfunction
- Trial name
- AVALON (NCT03808324)
- Testing
- Diagnostic investigations
- Where
- Sweden
- Volunteers
- 100 people
- Sponsor
- Sahlgrenska University Hospital
Transplantation, Heart-Lung, Chronic Lung Allograft Dysfunction
Evaluation of Electrical Impedance Tomography for the Diagnosis of Chronic Rejection in Lung Transplants Recipients
Electrical impedance tomography (EIT) is non-invasive and provides functional imaging of the lung and it could be a useful tool to diagnose chronic lung allograft dysfunction (CLAD) and specially Bronchiolitis Obliterans Syndrome…
- Conditions
- Transplantation, Heart-Lung, Chronic Lung Allograft Dysfunction, Bronchiolitis Obliterans Syndrome
- Trial name
- CLAD (NCT02863835)
- Testing
- EIT, Salbutamol nebulisation and with CPAP
- Where
- United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Allosensitization, Heart Transplant Failure and Rejection
Daratumumab-SC for Highly Sensitized Patients Awaiting Heart Transplantation
The purpose of this study is to test whether Daratumumab-SC, a drug that eliminates antibody-producing plasma cells, can effectively lower the level of preformed antibodies in patients awaiting heart transplantation.
- Trial name
- NCT04610320
- Testing
- Daratumumab-SC
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Ronald Witteles
Heart Transplantation, End-stage Heart Failure
Donor Circadian Rhythm and Its Correlation With Prognosis After Heart Transplantation
The goal of this observational study is to learn about the impact of donor heart procurement time based on circadian rhythm on the long-term outcomes of heart transplant recipients.
- Conditions
- Heart Transplantation, End-stage Heart Failure, Circadian Rhythm
- Trial name
- CIRCA-HTx (NCT07301788)
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 Transplantation
Donor Derived Cell Free DNA (Dd-cfDNA) as a Biomarker for Allograft Rejection in Heart Transplant Recipients
Following heart transplantation (HTx), lifelong immunosuppressive treatment is required to prevent the immune system from attacking, damaging, and rejecting the donor hear (allograft).
- Trial name
- TRANSCEND (NCT07886489)
- Testing
- Donor-derived cell free DNA
- Where
- 3 sites in Denmark, Norway
- Volunteers
- 100 people
- Sponsor
- University of Aarhus
Renal Transplantation, Heart Transplantation
Intracellular and Renal/Myocardial Tissue Concentrations of Cyclosporine A (CsA) and Rejection Frequency Following Transplantation
The primary objective is to investigate intralymphocyte concentrations of CsA in renal and heart transplant recipients to elucidate the association between the intracellular concentration and efficacy (rejection episodes and…
- Trial name
- NCT00139009
- Testing
- Cyclosporine A
- Where
- Norway
- Volunteers
- 30 people
- Sponsor
- University of Oslo School of Pharmacy
Heart Transplant Rejection
Molecular Evidence of Rejection Intervention Trial
MERIT is a double-blind, multi-center, placebo-controlled, randomized clinical trial. Heart transplant recipients with dual-positive GEP/dd-cfDNA assays with a corresponding negative biopsy between 2 months and 2 years…
- Trial name
- MERIT (NCT07905599)
- Testing
- Prednisone
- Volunteers
- 200 people
- Sponsor
- CareDx
Acute Graft Rejection, Heart Transplantation
Detection of Acute Graft Rejection in Heart Transplant Patients by Estimation of T2
The investigators propose a simple and non-invasive method to monitor heart transplant patients with MRI. Its diagnostic and prognostic values have already been assessed in two monocentric studies.
- Trial name
- DRAGET (NCT02261870)
- Testing
- MRI T2 quantification
- Where
- 10 sites in France
- Volunteers
- 116 people
- Sponsor
- Central Hospital, Nancy, France
Transplant; Failure, Heart, Cardiac Allograft Vasculopathy
Impact of SGLT2 Inhibitors in Heart Transplant Recipients
The goal of this clinical trial is to test if SGLT2 inhibitors could prevent or delay the development of Cardiac Allograft Vasculopathy (CAV) post-heart transplantation (TxC).
- Conditions
- Transplant; Failure, Heart, Cardiac Allograft Vasculopathy, Rejection Heart Transplant
- Trial name
- NCT06147271
- Testing
- SGLT2i
- Where
- Brazil
- Volunteers
- 80 people
- Sponsor
- Universidade Federal do Ceara
Graft Rejection, Heart Diseases
A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection Early Post-transplantation
This study is designed to evaluate the safety and efficacy of a peripheral blood mononuclear cell gene expression profiling method (AlloMap) in monitoring asymptomatic heart transplant patients for acute rejection beginning 2-6…
- Trial name
- EIMAGE (NCT00962377)
- Testing
- Endomyocardial biopsy, AlloMap Molecular Testing
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- XDx