NCT05064462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

March 3, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2024

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

September 22, 2021

Last Update Submit

March 11, 2026

Conditions

VirusHeart Transplant RejectionHeart Transplant Infection

Keywords

TTV, Heart transplant, Viral Load, rejection, infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • TTV viral load

    3 months

  • TTV viral load

    12 months

  • Infections

    12 months

  • Rejections

    12 months

  • Immunosuppressant level

    3 months

  • +1 more secondary outcomes

Study Arms (1)

All the patients included in the study

50 patients, at least 18 years old, first heart transplant

Other: Collection of EDTA blood sample (5 to 7 ml)

Interventions

Collection of EDTA blood sample (5 to 7 ml)OTHER

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.

All the patients included in the study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with first heart transplant

You may qualify if:

  • Age ≥18 years
  • Heart transplant only
  • First transplant
  • Patient not having objected to carrying out the research
  • Affiliated to a French Health Insurance system.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital européen Georges Pompidou

Paris, 75015, France

Location

CHU de Rennes

Rennes, 35033, France

Location

CHU Strasbourg

Strasbourg, 67091, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

5-7 ml whole blood samples are taken at each monthly visit to measure viral load at the end of the study.

MeSH Terms

Conditions

Virus DiseasesLanger-Giedion SyndromeRejection, PsychologyInfections

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesSocial BehaviorBehavior

Study Officials

  • Hélène PERE, Pharm D, PhD

    Hôpital Européen Georges-Pompidou

    PRINCIPAL INVESTIGATOR

  • David VEYER, Pharm D, PhD

    Hôpital Européen Georges-Pompidou

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2021

First Posted

October 1, 2021

Study Start

March 3, 2022

Primary Completion

October 23, 2024

Study Completion

October 23, 2024

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Two years after the last publication
Access Criteria
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR(3)