An observational study in Heart Transplant Rejection, Heart Transplant Infection and Virus, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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.
913 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.
This study's enrollment of 60 is below the median of 300 across 274 observational studies indexed under Virus Diseases.
Browse Virus Diseases studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Adult patients with first heart transplant
Exclusion Criteria:
50 patients, at least 18 years old, first heart transplant
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.
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
Time frame: 12 months
TTV viral load
Monthly mean of TTV viral concentration load measured by quantitative PCR within 3 months
Time frame: 3 months
TTV viral load
Monthly mean of TTV viral concentration measured by quantitative PCR within 12 months
Time frame: 12 months
Infections
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
Rejections
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: 12 months
Immunosuppressant level
Immunosuppressant pharmacological dosing
Time frame: 3 months
Immunosuppressant level
Immunosuppressant pharmacological dosing
Time frame: 12 months
Plan to share: Yes — Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris