Clinical trials: Heart Transplant Recipients
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
Immunosuppression
Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients
This was a study to compare less intense immunosuppression with a more traditional approach. The hypothesis was that less immunosuppression will provide similar protection against rejection than typical 2-3 drug therapy.
- Trial name
- TICTAC (NCT00299221)
- Testing
- Tacrolimus, combination therapy
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- Newark Beth Israel Medical Center
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
Cardiorenal Syndrome, Chronic Allograft Nephropathy
Paricalcitol Versus Calcitriol for the Management of Renocardiac Syndrome in Renal Transplant Patients
We hypothesize that paricalcitol and calcitriol in dose-dependent manner are effective for the management of chronic allograft dysfunction (CAD), protection and repair of kidney and heart, management of chronic renocardiac…
- Trial name
- NCT01265615
- Testing
- Paricalcitol, Calcitriol, Cholecalciferol
- Where
- 2 sites in Netherlands, Russia
- Volunteers
- 109 people
- Sponsor
- Ural State Medical University
Cardiac Allograft Vasculopathy, Heart Transplant Recipients
Prevention of Cardiac Allograft Vasculopathy Using Rituximab (Rituxan) Therapy in Cardiac Transplantation
All people who have a heart transplant are at risk for developing cardiac allograft vasculopathy (CAV). CAV means narrowing of the heart transplant vessels, which is associated with poor heart transplant function.
- Trial name
- NCT01278745
- Testing
- Rituximab induction/conventional immunosuppression (tacrolimus, MMF, and steroid taper)
- Where
- 24 sites in United States
- Volunteers
- 362 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Disorder Related to Cardiac Transplantation
Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation
This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.
- Trial name
- NOCTET (NCT00377962)
- Testing
- Everolimus, Mycophenolic acid (MPA)/azathioprine (AZA), Calcineurin inhibitors (CNI)
- Where
- 6 sites in Denmark, Norway and 1 more
- Volunteers
- 282 people
- Sponsor
- Novartis Pharmaceuticals
Heart Transplant Recipients
Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients
Iron deficiency is prevalent in heart transplant recipients, and may be associated with reduced functional capacity. The IronIC trial is designed to assess the effect of intravenous iron isomaltoside on exercise capacity, muscle…
- Trial name
- IronIC (NCT03662789)
- Testing
- Iron Isomaltoside 1000
- Where
- Norway
- Volunteers
- 102 people
- Sponsor
- Oslo University Hospital
Cardiac Allograft Vasculopathy
Endothelin-1 and Cardiac Allograft Vasculopathy (CAV)
Many patients with end-stage heart failure, a condition in which the heart fails to pump enough blood to support the body's other organs, are fortunate enough to receive a heart transplant.
- Trial name
- NCT05373108
- Testing
- Macitentan
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- University of California, Los Angeles
Heart Failure
HCV Positive Heart Donors
Study subjects active on the waiting list for a heart transplant at the NYU Langone Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from a donor who tests positive for HCV.
- Trial name
- NCT03382847
- Testing
- Transplant with HCV positive donor, followed by surveillance and treatment of viremia
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- NYU Langone Health
Pediatric Heart Transplantation, Pediatric Heart Transplant Recipients
Alloantibodies in Pediatric Heart Transplantation
The purpose of this study is to determine the clinical outcomes of sensitized pediatric heart transplant recipients with a positive donor-specific cytotoxicity crossmatch and to compare this group with outcomes in nonsensitized…
- Trial name
- NCT01005316
- Testing
- Induction Therapy, Tacrolimus, Mycophenolate Mofetil
- Where
- 8 sites in United States, Canada
- Volunteers
- 290 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gastrointestinal Symptoms, Heart Transplantation
Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of transplant rejection.
- Trial name
- NCT00574197
- Testing
- Mycophenolate Sodium
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Cedars-Sinai Medical Center
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
Cardiac Transplantation
Everolimus in de Novo Heart Transplant Recipients
The purpose of this study, in de novo heart transplant patients, is to evaluate whether delayed introduction of everolimus reduces the occurrence of wound healing problems, pericardial and/or pleural effusion and early acute…
- Trial name
- EVERHEART (NCT01017029)
- Testing
- Everolimus, Mycophenolate mofetil + Everolimus
- Where
- 12 sites in Italy
- Volunteers
- 182 people
- Sponsor
- Novartis Pharmaceuticals
Heart Transplantation, Liver Transplantation
Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant
The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record…
- Conditions
- Heart Transplantation, Liver Transplantation, Kidney Transplantation
- Trial name
- NCT02118896
- Testing
- FK506E
- Where
- 105 sites in United States, Australia and 21 more
- Volunteers
- 850 people
- Sponsor
- Astellas Pharma Europe Ltd.
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
Cytomegalovirus Disease, Cytomegalovirus Infections
Letermovir Use in Heart Transplant Recipients
This is an open label trial in which letermovir will be given as prophylaxis for the prevention of cytomegalovirus (CMV) infection and disease to all heart transplants who are at risk for cytomegalovirus.
- Conditions
- Cytomegalovirus Disease, Cytomegalovirus Infections, Heart Transplant Infection, Antiviral Toxicity
- Trial name
- NCT04904614
- Testing
- Letermovir
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Tufts Medical Center
Heart Transplantation
Pediatric Heart Transplantation: Transitioning to Adult Care
The purpose of this pilot trial, Transitioning to Adult Care (TRANSIT), is to develop and test an intervention (i.e., a standardized, tailored transition program focused on enhancing adherence) to improve outcomes for emerging…
- Trial name
- TRANSIT (NCT02090257)
- Testing
- TRANSIT
- Where
- 6 sites in United States
- Volunteers
- 88 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Solid Organ Transplant Recipient (Liver, Kidney, Heart), Rheumatologic Disorder
Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults
The purpose of this study is to determine whether Fluzone High Dose increases the immune response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone in immunocompromised children and young…
- Conditions
- Solid Organ Transplant Recipient (Liver, Kidney, Heart), Rheumatologic Disorder, Human Immunodeficiency Virus (HIV), Bone Marrow Transplant (BMT)
- Trial name
- NCT01685372
- Testing
- Fluzone High Dose, Fluzone
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of Colorado, Denver
Heart Failure, Cardiomyopathy
Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients
The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe.
- Conditions
- Heart Failure, Cardiomyopathy, Ventricular Dysfunction
- Trial name
- NCT02362646
- Testing
- MPC Intramyocardial Injection, Control Solution
- Where
- 19 sites in United States, Canada
- Volunteers
- 159 people
- Sponsor
- Annetine Gelijns
Heart Transplant
Tocilizumab in Cardiac Transplantation
The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant.
- Trial name
- NCT03644667
- Testing
- tocilizumab, Standard of Care Triple IS
- Where
- 20 sites in United States
- Volunteers
- 385 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)