An observational study in Heart Transplant Rejection, sponsored by Vastra Gotaland Region. Completed at 4 sites in Sweden. Per ClinicalTrials.gov, last updated 2022-05-02.
Sponsored by Vastra Gotaland Region · Observational
This study is a prospective, observational multi-center cohort study. The study will consist of patients undergoing heart transplantation. The main purpose is to test a new biomarker for rejection against the gold-standard, the endomyocardial biopsy (EMB). 80 patients will be included, both children and adults.
The primary objective is a comparison of an the established, invasive diagnostic test, the endomyocardial biopsy (EMB) against a new, non-invasive test. The new test is the measurement of donor-derived cell-free DNA (dd-cfDNA) circulating in the blood stream of the recipient, quantified by droplet digital PCR (polymerase-chain reaction) after targeted multiplex preamplification. Sensitivity is calculated with EMB as the gold standard. The patients will be followed during one year post-transplantation with simultaneous blood samples and EMB. The patients will further be followed clinically for 5 years. A suitable cut-off for the ratio of dd-cfDNA will be calculated using receiver operating characteristic (ROC) analysis.
Secondary objectives are description of patient outcomes with respect to organ function, quality of life and adverse events.
Secondary objectives are the calculation of the costs related to the transplantation process as well as to the follow-up with EMB. A simulation will be done with respect to possible savings achieved if the new biomarker could be implemented.
The study consists of two cohorts: all adult recipients of heart transplantation at Sahlgrenska University Hospital (one of two center conducting heart transplantation in Sweden): regional study. The other cohort consists of all children undergoing heart transplantation in Sweden:national study. Patients will undergo transplantation at Sahlgrenska University Hospital in Gothenburg as well as at Skåne University Hospital in Lund. Follow-up with blood samples and EMB of these patients will be in Gothenburg, Lund and at Karolinska University Hospital in Stockholm.
Vastra Gotaland Region is the lead sponsor of 275 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients on waiting list for heart transplantion at the participating centers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients (18 years or older) undergoing heart transplantation
Diagnostic Test: donor-derived cell-free DNA (dd-cfDNA)
Pediatric patients (0-17 years) undergoing heart transplantation
Diagnostic Test: donor-derived cell-free DNA (dd-cfDNA)
Measurement of dd-cfDNA and comparison against grade of rejection as measured by endomyocardial biopsy, taken simultaneously
Comparison of donor-derived cell-free DNA and endomyocardial biopsy with respect to rejection
Measurement of both fraction of donor-derived cell-free DNA of all cell-free DNA (derived from recipient and donor) as well as the absolute number of copies per ml plasma derived from the donor. Comparison is made with simultaneously obtained endomyocardial biopsies that are graded with respect to rejection, according to the official guidelines provided by the International Society of Heart and Lung Transplantation.
Time frame: 3 years
Cost analysis 1
Costs of heart transplantation during the first year post-transplantation
Time frame: 5 years
Rejection
Cumulative incidence of rejection (according to the biopsy grading system provided by the International Society of Heart and Lung Transplantation)
Time frame: 5 years
Graft-vasculopathy
Cumulative incidence of graft-vasculopathy
Time frame: 5 years
Overweight
Prevalence of overweight (BMI \>25) and obesity (BMI\>30)
Time frame: 5 years
Quality of life
Health-related quality of life as measured by EQ5D
Time frame: 5 years
Survival
Survival
Time frame: 5 years
Re-transplantation
Proportion of patients who have undergone re-transplantation
Time frame: 5 years
GFR (glomerular filtration rate)
Renal function evaluated by calculated and measured GFR (Iohexol or Cr-Clearance)
Time frame: 1 year
GFR (glomerular filtration rate)
Renal function evaluated by calculated and measured GFR (Iohexol or Cr-Clearance)
Time frame: 3 years
GFR (glomerular filtration rate)
Renal function evaluated by calculated and measured GFR (Iohexol or Cr-Clearance)
Time frame: 5 years
Infections
Cumulative incidence of infections requiring hospital admission
Time frame: 5 years
Circulatory support to transplantation
Proportion of patients undergoing heart transplantation from a ventricular assist device or extra-corporeal membrane oxygenation (ECMO) or from mechanical ventilation.
Time frame: 5 years
Immunization status
Impact of pre-transplantation immunization status on primary and secondary outcomes
Time frame: 5 years
Malignancy
Cumulative incidence of malignancy (post-transplantation lymphoproliferative disorder PTLD and others)
Time frame: 3 years
Malignancy
Cumulative incidence of malignancy (PTLD and others)
Time frame: 5 years
Prior cardiac surgery
Impact of prior cardiac surgery on other outcomes
Time frame: 5 years
Neonatal cardiac surgery
Impact of neonatal (first 4 weeks of life) cardiac surgery on other outcomes
Time frame: 5 years
Donor cardiac arrest
Correlation between circulatory arrest in the donor and cardiac function
Time frame: 5 years
Donor cardiopulmonary resuscitation (CPR) impact
Impact of CPR of the donor on the incidence of assumed early rejection
Time frame: 3 years
Initial immunosuppression
Correlation between initial immunosuppression and the incidence of rejection
Time frame: 5 years
Initial immunosuppression and malignancy
Correlation between type of initial immunosuppression and incidence of malignancy
Time frame: 5 years
Immunosuppression and adverse effects
Correlation of time points with over- or under-immunosuppression (as measured by blood levels of immunosuppressive drugs and comparison with desired levels) and the incidence of severe infection, renal function decline and malignancy
Time frame: 5 years
Immunosuppression and rejection
Correlation of time points with over- or under-immunosuppression (as measured by blood levels of immunosuppressive drugs and comparison with desired levels) with rejection events
Time frame: 5 years
Ischemia time
Correlation between ischemic graft time and cardiac function as measured by echocardiography
Time frame: 5 years
Blood products and adverse events
Correlation between the number of blood products (red blood cells, thrombocytes, plasma) given after transplantation and the incidence of adverse effects
Time frame: 5 years
Survival
Survival
Time frame: 3 years
Plan to share: Undecided — Not decided yet.
No publications or documents are linked to this record.
Ran from Mar 2016 to primary completion in Dec 2021, 69 months.
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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