Heart Transplant RejectionTTVCoeurNCT05064462
TTV Viral Load in Heart Transplant Recipients
An observational study of Heart Transplant Rejection and Heart Transplant Infection, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant Rejection, Heart Transplant Infection, Virus
- What is being tested?
- Collection of EDTA blood sample (5 to 7 ml)
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Mar 2022to 23 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with first heart transplant
Who may be able to join
- Age ≥18 years
- Heart transplant only
- First transplant
- Patient not having objected to carrying out the research
- Affiliated to a French Health Insurance system.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital européen Georges Pompidou
Paris, 75015
CHU de Rennes
Rennes, 35033
CHU Strasbourg
Strasbourg, 67091
About this study
Official title: Association Between TTV Viral Load and the Occurrence of Infections and Rejection in Heart Transplant Recipients
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.
Read the 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.
- Being tested
- Collection of EDTA blood sample (5 to 7 ml)
- Keywords
- TTV, Heart transplant, Viral Load, rejection, infection
- Medical subject headings
- Virus Diseases, Langer-Giedion Syndrome, Rejection, Psychology, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| All the patients included in the study | 50 patients, at least 18 years old, first heart transplant Receives: Other: Collection of EDTA blood sample (5 to 7 ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (6)
TTV viral load
Monthly mean of TTV viral concentration load measured by quantitative PCR within 3 months
Measured: 3 months
TTV viral load
Monthly mean of TTV viral concentration measured by quantitative PCR within 12 months
Measured: 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.
Measured: 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.
Measured: 12 months
Immunosuppressant level
Immunosuppressant pharmacological dosing
Measured: 3 months
Immunosuppressant level
Immunosuppressant pharmacological dosing
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start3 Mar 2022
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Sponsor
- Investigators
- Hélène PERE, Pharm D, PhD, Principal investigator, Hôpital Européen Georges-PompidouDavid VEYER, Pharm D, PhD, Study director, Hôpital Européen Georges-Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064462
- Sponsor's protocol ID
- APHP201167
- Other IDs
- 2020-A03456-33
- Acronym
- TTVCoeur
- Status last verified
- Mar 2026
- First submitted
- 22 Sep 2021
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between TTV Viral Load and the Occurrence of Infections and Rejection in Heart Transplant Recipients
- ClinicalTrials.gov ID
- NCT05064462
- Acronym / sponsor ID
- TTVCoeur / APHP201167
- Keywords
- TTV, Heart transplant, Viral Load, rejection, infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All the patients included in the study | – | Other: Collection of EDTA blood sample (5 to 7 ml)50 patients, at least 18 years old, first heart transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with first heart transplant
Key inclusion criteria (5 listed)
- Age ≥18 years
- Heart transplant only
- First transplant
- Patient not having objected to carrying out the research
- Affiliated to a French Health Insurance system.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | All the patients included in the study |
Primary outcome
Composite outcome : Infections or Rejections
Time frame: 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
6 secondary outcomes
TTV viral load
Time frame: 3 months
TTV viral load
Time frame: 12 months
Infections
Time frame: 12 months
Rejections
Time frame: 12 months
Immunosuppressant level
Time frame: 3 months
Immunosuppressant level
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène PERE, Pharm D, PhD principal investigator
Hôpital Européen Georges-Pompidou
David VEYER, Pharm D, PhD study director
Hôpital Européen Georges-Pompidou
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant Rejection and Heart Transplant Infection, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome : Infections or Rejections (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.