Clinical trials: Heart Transplant Rejection
Cardiac Failure, Graft Rejection
Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs
This study aims to discover circulating microRNAs (associated with drug doses and levels) that can be used to characterize the overall immune state in pediatric heart transplant patients and predict patients that will go on to…
- Trial name
- OPTIMA (NCT06532890)
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- Northwestern University
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
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
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
Heart Transplant Rejection
Biomarkers for Diagnosis, Prognosis, and Targeted Therapy After Heart Transplantation
The objective of this prospective observational single center study is to investigate donor-derived cell-free DNA (ddcfDNA), peripheral blood platelet mRNA, peripheral blood extracellular vesicle mRNA, and peripheral blood…
- Trial name
- EMBIO (NCT06064123)
- Testing
- Cell-free DNA
- Where
- Finland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Helsinki University Central Hospital
Heart Transplant Rejection, Graft Failure
Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing Regimen
This phase II, single-center, open-label study will evaluate the comparable efficacy of tacrolimus extended release tablets (Envarsus®) to the standard of care (SOC) twice daily tacrolimus (Prograf®) dosing regimen post-cardiac…
- Conditions
- Heart Transplant Rejection, Graft Failure, Compliance, Patient
- Trial name
- Veloxis (NCT03373227)
- Testing
- Envarsus
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Baylor Research Institute
Heart Transplant Recipients
Autonomic Cardiovascular Control After Heart Transplantation
The purpose of this prospective study is to investigate denervation (ie. surgical cutting of autonomic nerves) and re-innervation (ie. growth of autonomic nerves) in heart transplant recipients. More specifically, we focus on: 1.
- Trial name
- AccHeart (NCT01759966)
- Where
- Norway
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Oslo University Hospital
Heart Transplant Rejection
Cardiac Transplant Metabolomics With and Without Rejection
Patient who received a heart transplant may develop organ rejection. Currently, an invasive biopsy of the heart needs to be performed to diagnose rejection.
- Trial name
- ANTIPARTICLE (NCT05772442)
- Testing
- Extra blood samples (5-10 mL) drawn
- Volunteers
- 100 people
- Sponsor
- Western University, Canada
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
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
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
Heart Transplantation, Graft Rejection
ZeroHeart Biopsy - Prediction of Deceased Donor Heart Transplant Performance From Organ Donors Using Pre-Transplant Biopsies - A Pilot Study
The goal of this observational study is to evaluate whether molecular analysis of donor heart biopsies taken at the time of organ removal ("Time Zero") can help predict the future function and rejection risk of the transplanted…
- Conditions
- Heart Transplantation, Graft Rejection, Myocardial Injury, Organ Preservation
- Trial name
- ZeroHeart (NCT06982404)
- Testing
- Time Zero Donor Heart Biopsy for Molecular Analysis
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Medical University of Vienna
Heart Transplantation
Magnetocardiography as a Non-Invasive Tool for Detecting Tissue Rejection in Heart Transplant Patients
Heart transplantation is a great procedure for selected patients with end-stage heart failure, but graft rejection remains a major factor limiting long-term survival despite continued advancement in the scientific skill of…
- Trial name
- NCT00169936
- Testing
- Magnetocardiograph
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mayo Clinic
Pediatric Heart Transplantation, Immunosuppression
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years.
- Conditions
- Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases, Cardiac Allograft Vasculopathy
- Trial name
- TEAMMATE (NCT03386539)
- Testing
- Everolimus, Tacrolimus, Mycophenolate Mofetil
- Where
- 25 sites in United States
- Volunteers
- 211 people
- Sponsor
- Boston Children's Hospital
Heart Transplant Rejection
Molecular Diagnosis of Heart Allograft Rejection Using Intra-Graft Targeted Gene Expression Profiling.
The goal of this observational study is to develop and validate a molecular heart rejection diagnostic system based on targeted transcriptome as a novel monitoring companion tool for heart allograft precision diagnostics…
- Trial name
- Nano-Heart (NCT06436027)
- Testing
- Nano-Heart tool: Intra-Graft Targeted Gene Expression Profiling
- Where
- 3 sites in United States, France and 1 more
- Volunteers
- 496 people
- Sponsor
- Paris Translational Research Center for Organ Transplantation
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
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
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
Pediatric Heart Transplant
Non-invasive Detection of Acute Cell-mediated Graft Rejection in Pediatric Heart Transplant Recipients
Acute cardiac rejection is currently diagnosed by endomyocardial biopsy (EMB), but multiparametric cardiac magnetic resonance (CMR) may be a non-invasive alternative by its capacity for myocardial structure and function…
- Trial name
- NCT06795958
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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