Clinical trials: Heart Transplant Failure and Rejection
Heart Failure, Liver Fibrosis
Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Magnetic resonance elastography is a novel non-invasive MRI technique to obtain stiffness of soft tissues such as liver, heart, kidneys, etc.
- Conditions
- Heart Failure, Liver Fibrosis, Cardiac Transplant Rejection, Aortic Aneurysms
- Trial name
- MRE (NCT01757730)
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Arunark Kolipaka
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
Heart Transplant Failure and Rejection
Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant
Immunosuppressive therapy is required to prevent organ rejection, however, dosing of immunosuppressive agents is complicated by patient-specific differences impacting the body's absorption and elimination of these agents.
- Trial name
- NCT04380311
- Testing
- Tacrolimus Dosing Support Tool
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- University of Utah
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 Failure and Rejection, Heart Failure
HEARTBiT: Multi-Marker Blood Test for Acute Cardiac Transplant Rejection
Heart transplantation is a life saving therapy for people with end stage heart failure. Acute rejection, a process where the immune system recognizes the transplanted heart as foreign and mounts a response against it, remains a…
- Conditions
- Heart Transplant Failure and Rejection, Heart Failure, Heart Diseases, Heart Failure，Congestive
- Trial name
- HEARTBiT (NCT03575910)
- Where
- 4 sites in United States, Canada
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Heart Transplant Failure and Rejection
Allograft Dysfunction in Heart Transplant
The investigators will evaluate for early evidence of cardiac allograft dysfunction by cardiac MRI and single cell sequencing to determine underlying molecular and macroscopic causes.
- Trial name
- NCT03102125
- Testing
- Regadenoson
- Where
- United States
- Volunteers
- 376 people
- Sponsor
- Paul Kim
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 Failure and Rejection
Bioelectrical Impedance Spectroscopy in Heart Transplantation: Tracking Post-Transplant Changes in Body Composition and Correlation With Conventional Preoperative Risk Assessment Modalities
Patients with marginal physiologic reserve, severe frailty, and/or malnutrition may be regarded as unsuitable candidates for advanced cardiac replacement therapies.
- Trial name
- BIS (NCT03373279)
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Baylor Research Institute
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
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, 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
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
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.
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 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
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
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
Cardiovascular Disease, Acute Rejection of Cardiac Transplant
Quantitative Detection of Circulating Donor-Specific DNA in Organ Transplant Recipients (DTRT-Multi-Center Study)
The primary goal of this Multicenter Study is to develop and to evaluate a method for measuring donor-specific cell free DNA in blood samples from transplant recipients as markers of rejection.
- Conditions
- Cardiovascular Disease, Acute Rejection of Cardiac Transplant, Cardiac Transplant Rejection, Heart Transplant Failure and Rejection
- Trial name
- DTRT (NCT02109575)
- Testing
- Blood Draw of up to 10 ml
- Where
- 8 sites in United States
- Volunteers
- 540 people
- Sponsor
- Medical College of Wisconsin
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
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