Clinical trial NCT05064462: TTV Viral Load in Heart Transplant Recipients
Official title: Association Between TTV Viral Load and the Occurrence of Infections and Rejection in Heart Transplant Recipients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Transplant Rejection
Heart Transplant Infection
Virus
Keywords: TTV, Heart transplant, Viral Load, rejection, infection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: BioMérieux
First posted: 2021-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with first heart transplant

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite outcome : Infections or Rejections
timeFrame: 12 months
Secondary outcomes:
measure: TTV viral load
timeFrame: 3 months
measure: TTV viral load
timeFrame: 12 months
measure: Infections
timeFrame: 12 months
measure: Rejections
timeFrame: 12 months
measure: Immunosuppressant level
timeFrame: 3 months
measure: Immunosuppressant level
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital européen Georges Pompidou
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
affiliation: Hôpital Européen Georges-Pompidou
name: Hélène PERE, Pharm D, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Européen Georges-Pompidou
name: David VEYER, Pharm D, PhD
role: STUDY_DIRECTOR
References: