Heart TransplantationCARIBIAMNCT06774365
CARdiac Imaging and BIomarkers in the Diagnosis of Antibody Mediated Rejection in Heart Transplantation
An observational study of Heart Transplantation and Rejection Heart Transplant, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplantation, Rejection Heart Transplant, HLA Antigens
- How many people
- 683 participants
- Where
- 4 sitesItaly
- Study dates
- 7 Nov 2024to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Not yet recruiting
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Bari, Bari, 70120
Tomaso Bottio, +39335328307, tomaso.bottio@uniba.it
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Luciano Potena, MD, 0512143725, scompenso.trapiantocuore@aosp.bo.it
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, 20162
Enrico Ammirati, 0264447791, enrico.ammirati@ospedaleniguarda.it
- Recruiting
Azienda Ospedaliera dei Colli
Naples, Napoli, 80131
Cristiano Amarelli, +393473311842, cristiano.amarelli@ospedalideicolli.it
About this study
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
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of fibrosis, edema and of altered T1 mapping values in patients with donor specific antibodies (DSA)
prevalence
Measured: 5 years
prevalence of patients with DSA among all the enrolled patients
prevalence
Measured: 5 years
Secondary outcomes (5)
differences in dd-cfDNA in patients with and without DSA
differences in dd-cfDNA
Measured: 5 years
differences in T-reg subpopulation in patients with and without DSA
differences in T-reg subpopulation
Measured: 5 years
differences in T-reg and dd-cfDNA in patients with and without abnormal CMR
differences in T-reg and dd-cfDNA
Measured: 5 years
change in DSA, biomarkers and CMR findings after vs before AMR treatment
change in DSA
Measured: 5 years
MACE occurrence
MACE occurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start7 Nov 2024
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- 683 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Azienda Ospedaliera dei Colli, ASST Grande Ospedale Metropolitano Niguarda
- Responsible party
- Sponsor
- Investigators
- Luciano Potena, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774365
- Sponsor's protocol ID
- CARIBIAM
- Other IDs
- PNRR-MCNT2-2023-12377618
- Acronym
- CARIBIAM
- Status last verified
- May 2026
- First submitted
- 9 Jan 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARdiac Imaging and BIomarkers in the Diagnosis of Antibody Mediated Rejection in Heart Transplantation
- ClinicalTrials.gov ID
- NCT06774365
- Acronym / sponsor ID
- CARIBIAM / CARIBIAM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 683 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Azienda Ospedaliera dei Colli, ASST Grande Ospedale Metropolitano Niguarda
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 14 Jan 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Age > 18 years
Key exclusion criteria (4 listed)
- Unplanned hospitalization for cardiovascular causes in the previous three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of fibrosis, edema and of altered T1 mapping values in patients with donor specific antibodies (DSA)
Time frame: 5 years
prevalence
prevalence of patients with DSA among all the enrolled patients
Time frame: 5 years
prevalence
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
Luciano Potena, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4 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 Transplantation and Rejection Heart Transplant, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in Italy.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luciano Potena, MD (0512143725, scompenso.trapiantocuore@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of fibrosis, edema and of altered T1 mapping values in patients with donor specific antibodies (DSA) (time frame: 5 years). The study lists 2 primary outcomes in all. 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 22 May 2026.