TTV Viral Load in Heart Transplant Recipients

Virus Clinical Trial

— TTVCoeur  

Official title:

Association Between TTV Viral Load and the Occurrence of Infections and Rejection in Heart Transplant Recipients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05064462
• Other study ID #: APHP201167
• Secondary ID: 2020-A03456-33
• Status: Active, not recruiting
• Start date: March 3, 2022
• Est. completion date: March 3, 2024

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 3, 2024
• Est. primary completion date: March 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Transplant Infection
• Heart Transplant Rejection
• Infections
• Virus

Intervention

Other:
• Collection 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.

Locations

Country	Name	City	State
France	Hôpital européen Georges Pompidou	Paris
France	CHU de Rennes	Rennes
France	CHU Strasbourg	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	BioMérieux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcome : Infections or Rejections	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	12 months
Secondary	TTV viral load	Monthly mean of TTV viral concentration load measured by quantitative PCR within 3 months	3 months
Secondary	TTV viral load	Monthly mean of TTV viral concentration measured by quantitative PCR within 12 months	12 months
Secondary	Infections	Time to viral infections , bacterial and parasitic infections requiring the establishment of anti-infectious treatment or hospitalization during the 12 months post-transplant.	12 months
Secondary	Rejections	Time to rejections within the 12 months post-transplant defined as acute type 2R or 3R cell rejections according to the ISHLT classification.	12 months
Secondary	Immunosuppressant level	Immunosuppressant pharmacological dosing	3 months
Secondary	Immunosuppressant level	Immunosuppressant pharmacological dosing	12 months