Clinical trials: Heart Transplant Rejection, active
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
Cardiac Allograft Vasculopathy
Early Post Transplant Cardiac Allograft Vasculopathy
Heart transplantation is an effective life-saving treatment for patients with end-stage heart disease. After a transplant, the new heart may develop narrowing in the arteries, causing heart failure, heart attacks and abnormal…
- Trial name
- ECAV (NCT03217786)
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- Ottawa Heart Institute Research Corporation
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
Cardiac Transplant Rejection
A Study of AI in Cardiac Transplant in Echocardiographic Analysis (ORACLE)
The purpose of this research is to detect episodes of rejection versus non-rejection after cardiac transplant and the diagnostic accuracy of an Artificial Intelligence (AI) algorithm using the data from an ECG (electrocardiogram)…
- Trial name
- ORACLE (NCT06178744)
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Mayo Clinic
Transplant Failure, Heart Transplant Rejection
MuLtimodality EvaluatiOn of aNtibody mEdiated Damage in Heart Transplantation (LEONE-HT)
Cross-sectional evaluation of antibody mediated injury in heart transplantation patients through a multimodal approach: electron microscopy, optic microscopy, immunohistochemistry techniques, transthoracic echocardiography…
- Conditions
- Transplant Failure, Heart Transplant Rejection, Antibody-mediated Rejection
- Trial name
- LEONE-HT (NCT05184426)
- Testing
- Echocardiogram, Cardiac magnetic resonance, Coronary angiography
- Where
- 3 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Juan Francisco Delgado Jimenez
Heart Transplant Rejection
Trifecta-Heart cfDNA-MMDx Study
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from heart transplants.
- Trial name
- NCT04707872
- Testing
- MMDx diagnostic test, Prospera, HLA antibody
- Where
- 12 sites in United States, Australia and 5 more
- Volunteers
- 300 people
- Sponsor
- University of Alberta
Rejection Heart Transplant
Extracellular Vesicles for Rejection Monitoring in Cardiac Transplantation
This study will analyze extracellular vesicle (EV)-derived protein profiles in heart transplantated patients during the first 15 months post-transplantation to investigate, if there are distinct EV-derived proteins or protein…
- Trial name
- ExoRejeCT (NCT07673536)
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Laurenz Kopp Fernandes
Transplant; Failure, Heart
Non-ischaemic Heart Preservation Versus Standard Cold Storage in Human Heart Transplantation
The overall aim of this study is to compare a new state-of-the-art ex-vivo organ preservation method with standard ischemic cold static storage of donor hearts in adult cardiac transplantation.
- Trial name
- NIHP2 (NCT04066127)
- Testing
- Non-ischemic heart preservation (NIHP), Standard ischemic cold static storage (SCS)
- Where
- Sweden
- Volunteers
- 66 people
- Sponsor
- Region Skane
Heart Transplant Failure and Rejection, Heart Transplant
Brazilian Clinical Registry of Heart Transplantation
Prospective cohort clinical study, registry-based, multicenter, national, with the consecutive inclusion of patients with a history of Heart Transplantation in Brazil.
- Trial name
- HESTIA (NCT06453148)
- Testing
- Non-interventions
- Where
- Brazil
- Volunteers
- 730 people
- Sponsor
- Hospital Israelita Albert Einstein
Heart Transplant Rejection, Microvascular Resistance
IMR-Heart Trasplant Study
Acute allograft rejection (AAR) is an important cause of morbi-mortality in heart transplant (HT) patients, particularly during the first year.
- Trial name
- NCT06656065
- Where
- 2 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Hospital Miguel Servet
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, Pediatric Heart Transplant
Non-invasive Prediction of EArly Cardiac rEjection
Acute rejection remains a major cause of morbidity and mortality in pediatric patients after heart transplant. In order to screen for rejection, most centers perform heart catheterizations with endomyocardial biopsies frequently…
- Conditions
- Heart Transplant, Pediatric Heart Transplant, Rejection, Cardiac MRI
- Trial name
- PEACE (NCT07770659)
- Where
- 22 sites in United States
- Volunteers
- 200 people
- Sponsor
- Vanderbilt University Medical Center
Heart Transplant Recipient
HEART-BC: Heart Transplant Evaluation Using Advanced Rejection Monitoring Tools - British Columbia
Evaluate whether integration of HeartCare (AlloMap + AlloSure) into routine post-transplant surveillance reduces the number of invasive endomyocardial biopsies (EMBx) in the first year post-transplant
- Trial name
- HEART-BC (NCT07819292)
- Volunteers
- 30 people
- Sponsor
- Cardiology Research UBC
Cardiac Failure, Graft Rejection
OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels
This study aims to develop and refine a microRNA (miR) biomarker panel that can be used to phenotype net immune state after heart transplantation using circulating miRs (associated with drug doses and levels).
- Trial name
- OPTIMAL (NCT06939751)
- Where
- 6 sites in United States
- Volunteers
- 250 people
- Sponsor
- Northwestern University
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 Transplant Rejection, Immune Suppression
Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients
We will conduct a two-group randomized controlled trial to examine the eMocha DOT intervention with pediatric HT recipients.In this population, medication nonadherence remains a primary cause of late acute rejection (LAR)…
- Conditions
- Heart Transplant Rejection, Immune Suppression, Pediatric Heart Transplant, Medication Nonadherence
- Trial name
- NCT05732779
- Testing
- DOT intervention
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- University of Florida
Heart Transplantation, Heart Transplant Rejection
A National Swedish Study Evaluating Dd-cfDNA for as a Diagnostic Biomarker for Rejection Surveillence in Heart Transplantation
The SweD-HTx-study is an observational, multicenter cohort study including adult HTx recipients from Skåne University Hospital (Lund), Sahlgrenska University Hospital (Gothenburg), and Karolinska University Hospital (Stockholm).
- Trial name
- SweD-HTx (NCT07531784)
- Testing
- dd-cfDNA
- Where
- Sweden
- Volunteers
- 120 people
- Sponsor
- Karolinska Institutet
Heart Transplant Failure and Rejection
A Clinical Study of Association Between Postoperative Dyslipidemia and Organ Rejection in Transplant Patients
Abnormal lipid metabolism is a common complication after organ transplantation, with pathological changes in lipid parameters occurring in approximately 60-80% of cardiac transplant recipients receiving triple immunotherapy with…
- Trial name
- NCT05994274
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Heart Transplantation
Superiority Assessment of Donor-derived Cell-FreE DNA ( Deoxyribonucleic Acid) for Cardiac Allograft REjection Monitoring
Heart transplantation (HTx) remains the gold-standard treatment for patients with end-stage heart failure refractory to the medical management, offering the best survival and quality of life.
- Trial name
- SAFE-CARE (NCT07897526)
- Testing
- non-invasive strategy based of the analysis of circulating dd-cfDNA (AlloSeq cfDNA assay), control
- Volunteers
- 352 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
CMV Viremia, Heart Transplant Infection
Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant
The purpose of this study is to compare the safety and efficacy of letermovir with valganciclovir for prevention of Cytomegalovirus (CMV) viremia in moderate to high risk serostatus heart transplant recipients.
- Conditions
- CMV Viremia, Heart Transplant Infection, Heart Transplant Failure and Rejection
- Trial name
- VALET-CMV (NCT07079735)
- Testing
- Letermovir, Valganciclovir
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- Columbia University