Acute Rejection of Cardiac TransplantINNOGRAFTRS001NCT04274712
Non-invasive Test for Acute Rejection Identification in Heart Transplanted Patients
An observational study of Acute Rejection of Cardiac Transplant, run by Myway Gentics Srl at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Rejection of Cardiac Transplant
- What is being tested?
- INNOGRAFT Heart Suite
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 3 Feb 2020to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart transplanted consecutive adult patients , who underwent their regular surveillance protocol during the first 3 years post intervention.
Who may be able to join
- To be eligible for the study, patients must fulfill all the following inclusion criteria.
- Age≥18 years;
- Heart transplanted during 2016-2019 and under surveillance for preventing acute rejection;
- Heart transplanted before 2016 but undergoing routinely or symptom-based surveillance for preventing acute rejection;
- Signed written informed consent for reuse of biosamples for research purposes; OR Signed written informed consent for study partecipation;
- Underwent at least 1 blood sampling at the same time of the EMB;
- Clinical data collected during at least 1 surveillance visit (same time of blood sampling and EMB) available;
- Availability of EMB readings for EMB performed at the same time of blood sampling.
Who cannot join
- They were subjected to re-transplantation
- They were subjected to multi-organ transplantation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- 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:
- Presence of rejection (Yes/No),
- 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.
- 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.
- Conditions
- Acute Rejection of Cardiac Transplant
- Being tested
- INNOGRAFT Heart Suite
- Keywords
- liquid biopsy, cfDNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INNOGRAFT Heart SuiteDiagnostic test
Liquid biopsy to identify acute rejection
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison with gold standard: endomyocardial biopsy
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.
Measured: 6 months
Secondary outcomes (2)
Comparison with ISHLT classification
- 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
Measured: 6 months
cfDNA modifiers
- To look for potential clinical modifiers of cfDNA levels, as quantitatively determined through INNOGRAFT Heart Suite, for every given rejection class
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start3 Feb 2020
- Primary completionJun 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Rejection of Cardiac TransplantStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myway Gentics Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia, Istituto Di Ricerche Farmacologiche Mario Negri
- Responsible party
- Sponsor
- Investigators
- Valentina Favalli, PhD, Study director, Myway Gentics Srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274712
- Sponsor's protocol ID
- INNOGRAFTRS001
- Acronym
- INNOGRAFTRS001
- Status last verified
- Feb 2020
- First submitted
- 15 Feb 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Statistical aalysisi will be available at the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Test for Acute Rejection Identification in Heart Transplanted Patients: a Pilot Retrospective Study
- ClinicalTrials.gov ID
- NCT04274712
- Acronym / sponsor ID
- INNOGRAFTRS001 / INNOGRAFTRS001
- Conditions
- Acute Rejection of Cardiac Transplant
- Keywords
- liquid biopsy, cfDNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Myway Gentics SrlIndustry (pharma, biotech, devices)
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia, Istituto Di Ricerche Farmacologiche Mario Negri
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 18 Feb 2020 (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.
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.
Detailed description
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.
- 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:
- Presence of rejection (Yes/No),
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart transplanted consecutive adult patients , who underwent their regular surveillance protocol during the first 3 years post intervention.
Key inclusion criteria (8 listed)
- To be eligible for the study, patients must fulfill all the following inclusion criteria.
- Age≥18 years;
- Heart transplanted during 2016-2019 and under surveillance for preventing acute rejection;
- Heart transplanted before 2016 but undergoing routinely or symptom-based surveillance for preventing acute rejection;
- Signed written informed consent for reuse of biosamples for research purposes; OR Signed written informed consent for study partecipation;
Key exclusion criteria (2 listed)
- They were subjected to re-transplantation
- They were subjected to multi-organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INNOGRAFT Heart SuiteLiquid biopsy to identify acute rejection | Diagnostic test | – |
Primary outcome
Comparison with gold standard: endomyocardial biopsy
Time frame: 6 months
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.
2 secondary outcomes
Comparison with ISHLT classification
Time frame: 6 months
cfDNA modifiers
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: Yes. Statistical aalysisi will be available at the end of the study
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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. This study is not recruiting at the moment.
Valentina Favalli, PhD study director
Myway Gentics Srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Rejection of Cardiac Transplant, run by Myway Gentics Srl at 1 site 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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison with gold standard: endomyocardial biopsy (time frame: 6 months). 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 18 Feb 2020.