Heart Transplantation Clinical Trial
— DRAGETOfficial title:
"Detection of Acute Rejection in Heart Transplant Patients by Mean of T2 Quantification With MRI" Open Transversal Clinical Trial With Repeated Measures
Verified date | May 2020 |
Source | Central Hospital, Nancy, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators propose a simple and non-invasive method to monitor heart transplant
patients with MRI. Its diagnostic and prognostic values have already been assessed in two
monocentric studies. Other monocentric studies based on related methods have confirmed the
investigators findings. These studies are insufficient to allow a large diffusion of the
technique. Only a large multi-centric study will change medical practices. In addition, this
project will spread the new method at a national level and will allow an assessment of its
practical usefulness in centres not familiar with MRI T2 quantification.
Furthermore, MRI seems to detect rejections at earlier stage than biopsy. A confirmation of
this observation could lead to a modification of diagnostic criteria of cardiac graft
rejection. The ultimate aim of the DRAGET project is to replace a strategy based solely on
biopsy with one based on a first-line MRI (with biopsy only when needed) for a more efficient
and earlier detection of rejection. This would constitute a major advance in patients
security and comfort as well as an economic improvement.
Status | Completed |
Enrollment | 116 |
Est. completion date | February 27, 2020 |
Est. primary completion date | February 27, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Heart transplant patient - Able to realize 4 couples Biopsy/MRI within 12 months after the transplant - Mandatory enrolment in a social security plan - Patient having signed an informed consent. Exclusion Criteria: - Contraindication to MRI: pacemaker, ferromagnetic foreign body, etc - Impossibility to undergo MRI: claustrophobia, morbid obesity, hospitalisation in intensive care unit, arrhythmia - Pregnancy - Patients under a measure of legal protection |
Country | Name | City | State |
---|---|---|---|
France | Hospices Civils de Lyon | Bron | |
France | CHU Grenoble | La Tronche | |
France | CHRU Nancy Brabois | Nancy | |
France | CHU de Nantes | Nantes | |
France | Groupe Hospitalier Pitié-Salpêtrière | Paris | |
France | Hôpital Européen Georges Pompidou | Paris | |
France | CHU Bordeaux | Pessac | |
France | CHU de Rennes | Rennes | |
France | Hopitaux Universitaires de Strasbourg | Strasbourg | |
France | CHU de Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and specificity of myocardial T2 assessed with MRI for the diagnosis of histological heart graft rejection (with 95% confidence interval). | endpoint = sensitivity and specificity acute rejection means presence of damaged myocytes in endomyocardial biopsy (former grade 2, grade 2R and grade 3R) | 3 years after first inclusion | |
Secondary | Incidence of histological or clinical rejection within months of a couple MRI/biopsy with normal biopsy (grade<2R). | endpoint = number of rejections For this purpose, rejection will be defined as: a) acute rejection documented by presence of damaged myocytes in endomyocardial biopsy (former grade 2, grade 2R and grade 3R), or b) marked decrease in left ventricle ejection fraction (>10%), reversible after subsequent increase in immunosuppressive treatment. | 3 years after first inclusion | |
Secondary | Complications with MRI and with biopsies. | endpoint = Number of adverse events due to both exams | 3 years after first inclusion | |
Secondary | Magnitude of better tolerability of MRI over biopsies for the patient. | endpoint = Physical and psychological distress assessed by questionnaire using Likert scales. This questionnaire will be completed by the patients. | 3 years after first inclusion | |
Secondary | Inter-observer reproducibility of T2 quantification with MRI and of pathological grading of the biopsies. | endpoint = 95% interobserver limit of agreement for T2 quantification and Cohen's Kappa coefficient for histological grading. | 3 years after first inclusion | |
Secondary | Level of confidence, at the end of the study, of the expert-physicians of each centre concerning the use of T2 quantification as an alternative to routine biopsies. | endpoint = Confidence assessed by questionnaire using Likert scales. This questionnaire will be completed by study investigators at the end of the study. | 3 years after first inclusion |
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