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Detection of Acute Graft Rejection in Heart Transplant Patients by Estimation of T2 (DRAGET)

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ClinicalTrials.gov Identifier: NCT02261870
Recruitment Status : Completed
First Posted : October 10, 2014
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Acute Graft Rejection Heart Transplantation Device: MRI T2 quantification Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: "Detection of Acute Rejection in Heart Transplant Patients by Mean of T2 Quantification With MRI" Open Transversal Clinical Trial With Repeated Measures
Actual Study Start Date : February 18, 2015
Actual Primary Completion Date : February 27, 2020
Actual Study Completion Date : February 27, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ALL_patients
MRI T2 quantification : heart transplant patients will have 4-6 MRI exams for T2 quantification during their first year after transplantation.
 Device: MRI T2 quantification
MRI acquisitions will be performed according to the already described method based on conventional Fast Spin Echo sequences and with an additional calibration pad positioned on the patient thorax (dedicated pad made by the Nancy CIC-IT with stable and adapted T2). MRI will be performed if possible before the biopsy and otherwise the radiologist will be kept blinded of the biopsy results.


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity and specificity of myocardial T2 assessed with MRI for the diagnosis of histological heart graft rejection (with 95% confidence interval). [ Time Frame: 3 years after first inclusion ]
    endpoint = sensitivity and specificity acute rejection means presence of damaged myocytes in endomyocardial biopsy (former grade 2, grade 2R and grade 3R)


Secondary Outcome Measures :
  1. Incidence of histological or clinical rejection within months of a couple MRI/biopsy with normal biopsy (grade<2R). [ Time Frame: 3 years after first inclusion ]
    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.

  2. Complications with MRI and with biopsies. [ Time Frame: 3 years after first inclusion ]
    endpoint = Number of adverse events due to both exams

  3. Magnitude of better tolerability of MRI over biopsies for the patient. [ Time Frame: 3 years after first inclusion ]
    endpoint = Physical and psychological distress assessed by questionnaire using Likert scales. This questionnaire will be completed by the patients.

  4. Inter-observer reproducibility of T2 quantification with MRI and of pathological grading of the biopsies. [ Time Frame: 3 years after first inclusion ]
    endpoint = 95% interobserver limit of agreement for T2 quantification and Cohen's Kappa coefficient for histological grading.

  5. 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. [ Time Frame: 3 years after first inclusion ]
    endpoint = Confidence assessed by questionnaire using Likert scales. This questionnaire will be completed by study investigators at the end of the study.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261870


Locations
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France
Hospices Civils de Lyon
Bron, France, 69677
CHU Grenoble
La Tronche, France, 38700
CHRU Nancy Brabois
Nancy, France
CHU de Nantes
Nantes, France, 44093
Hôpital Européen Georges Pompidou
Paris, France, 75015
Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75651
CHU Bordeaux
Pessac, France, 33604
CHU de Rennes
Rennes, France, 35033
Hopitaux Universitaires de Strasbourg
Strasbourg, France
CHU de Tours
Tours, France, 37044
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Laurent Bonnemains, MD, PhD INSERM, IADI U47, Nancy, France
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02261870    
Other Study ID Numbers: 2014-A00848-39
CIC1433 ( Other Identifier: 12-109_DRAGET )
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Keywords provided by Central Hospital, Nancy, France:
MRI, T2 quantification