TTV Viral Load in Heart Transplant Recipients

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

TTV (Torque Teno Virus) is a ubiquitous virus that is not associated with any disease. A correlation exists between the level of TTV replication and the subject's immunocompetence: weak or non-existent in immunocompetents, very high in immunocompromised patients. In heart transplant patients, pharmacological dosing of immunosuppressants prevents their toxic manifestations but is not correlated with individual immune competence. Only clinical manifestations of overdose (infections) or under dosage (rejections) currently allow optimization of immunosuppressants. A predictive biomarker of these clinical manifestations upstream of their appearance would revolutionize the management of these patients. The TTV fulfills the conditions to be an ideal biomarker: classic blood sampling, possible follow-up in all patients, low cost, carrying out the analysis on already existing molecular biology platforms, reproducibility of inter- and intra-laboratory results, defined thresholds for the reliable interpretation of the results. We believe that this marker will provide the clinician with a useful tool for the management of immunosuppressants and the patient with personalized medicine which will allow their management to be individualized. If this study confirms the expected results, then it will allow, secondly, the setting up of interventional studies to validate the TTV viral load as a biomarker, and a tool for piloting immunosuppressive treatment. The TTV viral load of heart transplant patients will be follow during the first year after transplantation. A tube of blood will be taken during the transplant and then once or twice a month. Samples will be taken at the same time as those taken as part of standard care. The TTV viral load will be measured at the end of the study. The occurrence of events of interest (infections and rejections) will be collected at each corresponding visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05064462
Study type	Observational
Source	Assistance Publique - Hôpitaux de Paris
Contact
Status	Active, not recruiting
Phase
Start date	March 3, 2022
Completion date	March 3, 2024

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See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05205551` - Prospera Test Evaluation in Cardiac Transplant (ProTECT)
Not yet recruiting	`NCT05732779` - Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients	N/A
Recruiting	`NCT04973943` - Donor-derived Cell Free DNA as a New Biomarker in Cardiac Acute Rejection
Completed	`NCT03477383` - A New Biomarker for the Non-invasive Diagnosis of Rejection After Heart Transplantation
Not yet recruiting	`NCT05772442` - Cardiac Transplant Metabolomics With and Without Rejection
Recruiting	`NCT04707872` - Trifecta-Heart cfDNA-MMDx Study
Recruiting	`NCT06064123` - Biomarkers for Diagnosis, Prognosis, and Targeted Therapy After Heart Transplantation
Active, not recruiting	`NCT04921774` - Research on Patients With Heart Transplantation
Recruiting	`NCT04226521` - Extracorporeal Photopheresis and Early Cardiac Graft Vasculopathy	N/A
Completed	`NCT03393793` - HEart trAnsplantation Registry of piTie-Salpetriere University Hospital
Completed	`NCT01136135` - Cardiac Magnetic Resonance Imaging (CMRI) for Detection of Cardiac Transplant Rejection	N/A
Completed	`NCT03833050` - The TOGETHER Project - Heart
Active, not recruiting	`NCT03373227` - Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing Regimen	Phase 2
Active, not recruiting	`NCT03695601` - Surveillance HeartCare® Outcomes Registry
Active, not recruiting	`NCT01397812` - Heartsbreath Test for Heart Transplant Rejection	N/A
Active, not recruiting	`NCT05184426` - MuLtimodality EvaluatiOn of aNtibody mEdiated Damage in Heart Transplantation (LEONE-HT)

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

TTV Viral Load in Heart Transplant Recipients — TTVCoeur

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms