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Heart Transplant Infection clinical trials

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NCT ID: NCT06464016 Recruiting - Infections Clinical Trials

Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.

VADINFECT
Start date: July 4, 2023
Phase:
Study type: Observational

Heart failure is a major cause of mortality and morbidity in children. Heart transplantation can significantly improve the prognosis of patients with severe heart failure, but access is limited by a shortage of transplants. Long-term mechanical circulatory support is a major advance in the management of heart failure and can provide haemodynamic support while awaiting myocardial recovery or heart transplantation. The Berlin Heart (BH) EXCOR is the only long-term support system available for children. Despite technical and medical advances in circulatory support, infection is a common complication and a major cause of morbidity and mortality in patients on BH. There are few studies on the management of infection with mechanical support. Current ISHLT (International Society for Heart and Lung Transplantation) recommendations are based on expert opinion and observational studies. Some experts recommend anti-infective therapy until transplantation for specific support infections or for support-associated infections with persistent bacteraemia.

NCT ID: NCT06428097 Recruiting - Clinical trials for Heart Transplant Infection

Levothyroxine Supplementation for Heart Transplant Recipients

Levo
Start date: March 29, 2024
Phase: Phase 1
Study type: Interventional

This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.

NCT ID: NCT05064462 Active, not recruiting - Virus Clinical Trials

TTV Viral Load in Heart Transplant Recipients

TTVCoeur
Start date: March 3, 2022
Phase:
Study type: Observational

This prospective, multicenter, non-interventional trial aims to study the association between TTV viral load and the occurrence of rejection or infection during the first year after transplantation. The TTV viral loads, taken once a month during the first year after the transplant, will be measured at the end of the study.

NCT ID: NCT04904614 Active, not recruiting - Neutropenia Clinical Trials

Letermovir Use in Heart Transplant Recipients

Start date: October 1, 2021
Phase: Phase 4
Study type: Interventional

This is an open label trial in which letermovir will be given as prophylaxis for the prevention of CMV infection and disease to all heart transplants who are at risk for cytomegalovirus. The study will compare a 30 patient prospective cohort to a retrospective cohort of 374 heart transplant recipients for the rates of neutropenia. In addition, the tolerability of letermovir will be assessed in this population.

NCT ID: NCT04508907 Recruiting - Hepatitis C Clinical Trials

A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients

Start date: September 10, 2020
Phase: Phase 4
Study type: Interventional

This study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient.

NCT ID: NCT04278547 Recruiting - CMV Infection Clinical Trials

Multicenter Clinical Trial to Evaluate the Efficacy of a Preventive Strategy Against CMV Infection in Heart Transplant Patients, Based on the Specific T Cells Response

ELISPOT-TC
Start date: June 12, 2020
Phase: Phase 4
Study type: Interventional

This study evaluates the efficacy and safety of an individualized preventive strategy against CMV infection in CMV seropositive heart transplant patients based on the specific basal response of the lymphocytes againts CMV (ELISPOT Interferon-γ assay). In two thirds of the patients a preventive strategy will be carried out based on the result of the ELISPOT IFN-γ assay and in one third of the patients the standard of care strategy will be carried out (universal prophylaxis).

NCT ID: NCT04017338 Recruiting - Hepatitis C Clinical Trials

Transplantation Using Hepatitis C Positive Donors, A Safety Trial

Start date: August 6, 2018
Phase: Phase 3
Study type: Interventional

The success of transplantation is significantly hindered by the lack of sufficient number of available donors. Many potential donor organs cannot be utilized in clinical transplantation because donors have chronic viral infections such as hepatitis C (HCV) infection. This study will test the possibility of safely transplanting organs from HCV-infected donors into HCV-uninfected recipients. Prior to transplantation, recipients will receive an initial dose of highly effective antiviral prophylaxis using approved direct-acting antivirals (DAAs) Glecaprevir/Pibrentasvir (G/P) and they will also receive ezetimibe, a cholesterol-lowering medication that also blocks entry of HCV into liver cells. They will then receive daily dosing of the same medications for 7 days after transplant. The aim of the study is to show that transplantation of organs from HCV+ donors is safe in the era of DAAs. The investigators hypothesize that rates of HCV transmission to recipients will be prevented by the use of DAA prophylaxis and any HCV transmission that does occur will be readily treatable and curable. If successful, the knowledge from this study can have a large impact to patients with end stage organ diseases by providing a large novel source of donors for organ transplantations.

NCT ID: NCT03924219 Active, not recruiting - Clinical trials for Kidney Transplant Infection

CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients

Start date: June 3, 2019
Phase:
Study type: Observational

CMV infection and disease remain a significant clinical challenge for pediatric solid organ transplant (SOT) recipients. Current prevention strategies are limited to prophylaxis in which antiviral medication is administered for a period of several months or preemption in which close monitoring of CMV viral load from the peripheral blood is performed and treatment is initiated when CMV is detected. Each of these strategies has risks, costs, and limitations associated with it. Recently, assays for measurement of an individual patient's CMV immunity have been developed and are clinically available. One of these is the Viracor CMV T cell Immunity Panel. This flow cytometry based assay is performed on peripheral blood and measures cytokine release in response to CMV antigen stimulation by flow cytometry. The thresholds for this assay that confer protection against CMV infection in pediatric SOT recipients are not known. Defining CMV-specific cell mediated immune response thresholds that confer protection against CMV reactivation could inform patient specific durations of antiviral prophylaxis or pre-emptive surveillance testing. Therefore, the objective of this study is to quantify CMVresponsive T lymphocyte populations by flow cytometry (Viracor CMV T cell Immunity Panel) in pediatric heart, kidney, and liver transplant recipients within the first year of transplantation and to investigate potential threshold values that correlate with protection against CMV infection (DNAemia).

NCT ID: NCT03386539 Active, not recruiting - Clinical trials for Chronic Kidney Diseases

Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score

TEAMMATE
Start date: January 29, 2018
Phase: Phase 3
Study type: Interventional

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. Half of the participants will receive everolimus and low-dose tacrolimus and the other half will receive tacrolimus and mycophenolate mofetil. The trial will determine which treatment is better at reducing the cumulative risk of coronary artery vasculopathy, chronic kidney disease and biopsy proven-acute cellular rejection without an increase in graft loss due to all causes (e.g. infection, PTLD, antibody mediated rejection).