Heart Transplant Rejection Clinical Trial
— TTVCoeurOfficial title:
Association Between TTV Viral Load and the Occurrence of Infections and Rejection in Heart Transplant Recipients
Verified date | February 2024 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital européen Georges Pompidou | Paris | |
France | CHU de Rennes | Rennes | |
France | CHU Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | BioMérieux |
France,
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 |
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