Acute Rejection of Cardiac Transplant Clinical Trial
Official title:
Non-invasive Test for Acute Rejection Identification in Heart Transplanted Patients: a Pilot Retrospective Study
Aim of the study is to test INNOGRAFT Heart Suite in a clinical setting, using a previously collected set of plasma samples from patients who underwent heart transplant and routinely or symptoms-based surveillance during the period 2016- 2019.
Aim of the study is to test INNOGRAFT Heart Suite in a clinical setting, using a previously
collected set of plasma samples from patients who underwent heart transplant and routinely or
symptoms-based surveillance during the period 2016- 2019.
1. Primary end-point
• To evaluate specificity and sensitivity of INNOGRAFT Heart Suite in identifying
transplant rejection, using blood samples collected from heart transplanted patients
during the same day of endomyocardial biopsy (EMB) using the histological study of EMB
specimen as reference technique.
We will evaluate:
1. Presence of rejection (Yes/No),
2. Correct classification of rejection according to ISHLT 2004 guidelines. Rejection
will be considered Yes if ISHLT 2004 grading is >1R. We chose ISHLT scale because
it has been previously used in studies aimed at sensitivity assessment of other
techniques (Deng et al. 2006) and because changes of therapeutic protocol are
usually considered in presence of rejection grade higher than 2R.
2. Secondary end-points
- To evaluate the accuracy of INNOGRAFT Heart Suite in discriminating between the
classes of rejection according to ISHLT 2004 guidelines using histological study of
heart samples from EMB as reference technique
- To look for potential clinical modifiers of cfDNA levels, as quantitatively
determined through INNOGRAFT Heart Suite, for every given rejection class. Expected
modifiers are inflammatory states not related to rejection and infections. We will
also consider the influence of other factors such as gender, age, pregnancy,
comorbidities such as other organ failure, diabetes, cancer.
- To find if a correlation between basal donor cfDNA levels, as quantitatively
determined through INNOGRAFT Heart Suite on blood samples routinely collected for
surveillance or symptoms-based surveillance, and clinical outcomes exists. Clinical
outcome considered will be rejection, arrythmias, graft failure, hospitalization,
death.
- To find if a correlation between donor cfDNA levels, as quantitatively determined
through INNOGRAFT Heart Suite on blood samples routinely collected for surveillance
or symptoms-based surveillance, and parameters of cardiac function obtained through
right heart catheterization exists. Cardiac catheterization will measure cardiac
index, left atrium wedge, right ventricle pressure, pulmonary artery avarage
pressure.
- To find if a correlation between donor cfDNA levels, as quantitatively determined
through INNOGRAFT Heart Suite on blood samples routinely collected for surveillance
or symptoms-based surveillance, and blood levels of calcineurin
inhibitor/proliferation inhibitor (in therapeutic range/outside therapeutic range)
exists in each patient and between patients. Calcineurin inhibitor, proliferation
inhibitor and steroids are routine therapy for patients who underwent heart
transplant. Blood levels are routinely measured in patient treated with calcineurin
inhibitor or proliferation inhibitor protocols. The aim is to identify through
cfDNA measure, the correct patient-specific level of immunosuppression.
- To find if differences in basal donor cfDNA levels, as quantitatively determined
through INNOGRAFT Heart Suite on blood samples routinely collected for surveillance
or symptoms-based surveillance, between rATG-treated and rATG-untreated patients
exist. rATG is intended as induction therapy protocol before heart transplant.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02109575 -
Quantitative Detection of Circulating Donor-Specific DNA in Organ Transplant Recipients (DTRT-Multi-Center Study)
|