Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PNRR-MCNT2-2023-12377618 | Other Grant/Funding Number | Ministero della salute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari | OTHER |
| Azienda Ospedaliera dei Colli | OTHER |
| ASST Grande Ospedale Metropolitano Niguarda | OTHER |
Not provided
Not provided
Not provided
Not provided
The goal of this observational study is to systematically assess the presence and distribution of CMR-defined inflammation and fibrosis in clinically stable HT recipients with DSA detected during active screening for AMR surveillance. The main outcome is to study the prevalence of fibrosis, edema and of altered T1 mapping values in patients with DSA and the prevalence of patients with DSA among all the enrolled patients
This is a multicentric prospective study with experimental sample collection. Therapy and procedures will be performed according to clinical practice and current guidelines. Caring physicians will be blinded to the results of study specific assays, which will not be used to change standard cynical decision making.
Patients will be enrolled in the study at the time of the DSA assay performed in the context of standard surveillance (yearly monitoring for anti-HLA antibodies is recommended by current guidelines and is part of routine clinical practice). At study entry patients will receive blood sampling to assay dd-cfDNA (centralized laboratory) and T-reg populations (local laboratory). Clinical characteristics, medical history, and results of standard laboratory tests will be collected at baseline.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| prevalence of fibrosis, edema and of altered T1 mapping values in patients with donor specific antibodies (DSA) | prevalence | 5 years |
| prevalence of patients with DSA among all the enrolled patients | prevalence | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| differences in dd-cfDNA in patients with and without DSA | differences in dd-cfDNA | 5 years |
| differences in T-reg subpopulation in patients with and without DSA | differences in T-reg subpopulation |
Not provided
Inclusion Criteria:
Age > 18 years
Exclusion Criteria:
Unplanned hospitalization for cardiovascular causes in the previous three months
Not provided
Not provided
Not provided
Clinically stable adult heart transplanted patients will be consecutively enrolled during the routinely outpatient evaluation in the participating centers after IRB approval.
Heart Failure and Transplant Unit of IRCCS AOUBO will be the project leader and coordinate the overall study. The investigators plan a one year period for the enrollment and eight months for the follow-up.
Patients will be treated and followed according to the routinary clinical practice of each participating center.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luciano Potena, MD | Contact | 0512143725 | scompenso.trapiantocuore@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| Luciano Potena, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari | Not yet recruiting | Bari | Bari | 70120 | Italy |
Not provided
Not provided
Not provided
Not provided
EDTA blood samples, from which cfDNA will be extracted.
| 5 years |
| differences in T-reg and dd-cfDNA in patients with and without abnormal CMR | differences in T-reg and dd-cfDNA | 5 years |
| change in DSA, biomarkers and CMR findings after vs before AMR treatment | change in DSA | 5 years |
| MACE occurrence | MACE occurrence | 5 years |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | Bologna | 40138 | Italy |
|
| ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | Milano | 20162 | Italy |
|
| Azienda Ospedaliera dei Colli | Recruiting | Naples | Napoli | 80131 | Italy |
|