Heart Transplant Infection, Heart Transplant Rejection, Virus
Conditions
Keywords
TTV, Heart transplant, Viral Load, rejection, infection
Brief 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.
Detailed 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.
Interventions
OTHERCollection of EDTA blood sample (5 to 7 ml)
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.
Sponsors
Assistance Publique - Hôpitaux de Paris
BioMérieux
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Heart transplant only * First transplant * Patient not having objected to carrying out the research * Affiliated to a French Health Insurance system.
Exclusion criteria
* Patient transplanted from more than one solid organ * Patient who has already been transplanted before * Patient under guardianship or curatorship * Patient under legal protection * Pregnant or breastfeeding woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite outcome : Infections or Rejections | 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: * Infections are defined as viral Infections , bacterial and parasitic infections requiring the establishment of anti-infectious treatment or hospitalization * Rejections are defined as acute type 2R or 3R cell rejections according to the ISHLT classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TTV viral load | 3 months | Monthly mean of TTV viral concentration load measured by quantitative PCR within 3 months |
| Infections | 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. |
| Rejections | 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. |
| Immunosuppressant level | 3 months | Immunosuppressant pharmacological dosing |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORHélène PERE, Pharm D, PhD
Hôpital Européen Georges-Pompidou
STUDY_DIRECTORDavid VEYER, Pharm D, PhD
Hôpital Européen Georges-Pompidou
Outcome results
None listed