CARdiac Imaging and BIomarkers in the Diagnosis of Antibody Mediated Rejection in Heart Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Transplantation, Rejection Heart Transplant, HLA Antigens. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed description
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.
Primary outcome measures
- prevalence of fibrosis, edema and of altered T1 mapping values in patients with donor specific antibodies (DSA) [Time frame: 5 years]
- prevalence of patients with DSA among all the enrolled patients [Time frame: 5 years]
Secondary outcome measures (5)
- differences in dd-cfDNA in patients with and without DSA [Time frame: 5 years]
- differences in T-reg subpopulation in patients with and without DSA [Time frame: 5 years]
- differences in T-reg and dd-cfDNA in patients with and without abnormal CMR [Time frame: 5 years]
- change in DSA, biomarkers and CMR findings after vs before AMR treatment [Time frame: 5 years]
- MACE occurrence [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Age > 18 years
- Post heart transplantation follow-up between 1 and 15 y
- Ambulatory clinical stable
- Left ventricular ejection fraction (LVEF) > 40% (as assessed by complete cardiac ultrasound within 3 months before the enrolment)
Exclusion criteria
- Unplanned hospitalization for cardiovascular causes in the previous three months
- Biopsy-proven cellular (2R or greater) or AMR (pAMR> 1 ) in the previous 3 months
- Any contraindication to CMR
- Known pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 4 centers
- Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari — Bari
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
- ASST Grande Ospedale Metropolitano Niguarda — Milan
- Azienda Ospedaliera dei Colli — Naples
Identifiers
NCT: NCT06774365 · CARIBIAM · PNRR-MCNT2-2023-12377618