NCT Number: NCT05064462
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.
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Notify Me18 year and older
All sexes
Observational
Hôpital européen Georges Pompidou, Paris, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For all the patients included in the study, the samples to measure the viral load will be taken during the transplantation, then at each of the consultations planned as part of the usual care during the first year post-transplant (at minimum once and maximum twice a month).
These samples will be taken at the same time as those taken as part of standard care.
Time frame: 12 months
The primary endpoint is a composite endpoint defined as time to infections (first and recurrences) or rejections (first and recurrences) within the 12 months post-transplant:
Time frame: 3 months
Monthly mean of TTV viral concentration load measured by quantitative PCR within 3 months
Time frame: 12 months
Monthly mean of TTV viral concentration measured by quantitative PCR within 12 months
Time frame: 12 months
Time to viral infections , bacterial and parasitic infections requiring the establishment of anti-infectious treatment or hospitalization during the 12 months post-transplant.
Time frame: 12 months
Time to rejections within the 12 months post-transplant defined as acute type 2R or 3R cell rejections according to the ISHLT classification.
Time frame: 3 months
Immunosuppressant pharmacological dosing
Time frame: 12 months
Immunosuppressant pharmacological dosing
Assistance Publique - Hôpitaux de Paris
Other
Association Between TTV Viral Load and the Occurrence of Infections and Rejection in Heart Transplant Recipients
Acronym: TTVCoeur
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