Heart Transplantation, HLA Antigens, Rejection Heart Transplant
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Azienda Ospedaliera dei Colli
ASST Grande Ospedale Metropolitano Niguarda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| prevalence of fibrosis, edema and of altered T1 mapping values in patients with donor specific antibodies (DSA) | 5 years | prevalence |
| prevalence of patients with DSA among all the enrolled patients | 5 years | prevalence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| differences in dd-cfDNA in patients with and without DSA | 5 years | differences in dd-cfDNA |
| differences in T-reg subpopulation in patients with and without DSA | 5 years | differences in T-reg subpopulation |
| differences in T-reg and dd-cfDNA in patients with and without abnormal CMR | 5 years | differences in T-reg and dd-cfDNA |
| change in DSA, biomarkers and CMR findings after vs before AMR treatment | 5 years | change in DSA |
| MACE occurrence | 5 years | MACE occurrence |
Countries
Italy
Contacts
CONTACTLuciano Potena, MD
PRINCIPAL_INVESTIGATORLuciano Potena, MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Outcome results
None listed