Non Invasive Detection of Cardiac Allograft Rejection by Circulating microRNAs (MIRRACLE)
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ClinicalTrials.gov Identifier: NCT02672683 |
Recruitment Status :
Completed
First Posted : February 3, 2016
Last Update Posted : April 19, 2021
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Condition or disease |
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Cardiac Transplantation |
Heart transplantation is the only available long-term treatment option for patients with terminal heart failure.
Despite considerable progress in immunosuppressive regimens, allograft rejection remains a major cause of graft loss.
Majority of cardiac allograft rejection are asymptomatic. Only severe rejection goes along with cardiac dysfunction. This clinical latency makes the cardiac rejection diagnostic difficult and has ruled modalities of detection of cardiac rejection.
The cornerstone of rejection diagnosis and post-transplant follow-up relies on endomyocardial biopsy (EMB) and classical histopathology assessment. Echocardiography and MRI are neither sensitive nor specific enough to replace EMB. Majority of transplant centers thus evaluate rejection using iterative protocol biopsies. These cardiac allograft monitoring protocols are heavy, with 15 to 20 EMB in the first year of transplantation and 1 to 2 EMB each year after the first year. EMB are invasive procedure with a low but not zero risk of severe adverse events. Repetition of EMB is associated with tricuspid regurgitation due to valvular complications. Moreover incidence of cardiac rejection explains the cost-effectiveness of EMBs: 50 to 70% of biopsies are normal.
The goal is thus to detect rejection in the blood by measuring expression levels of 4 circulating microRNAs in patients' sera by RT-PCR. The seric expression levels of these 4 circulating microRNAs will be compared to the histopathological diagnosis made on concomitant endomyocardial biopsy.
Study Type : | Observational |
Actual Enrollment : | 461 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Non Invasive Detection of Acute Rejection by Circulating microRNAs in Cardiac Transplantation: a Multicenter Prospective Study |
Actual Study Start Date : | September 26, 2016 |
Actual Primary Completion Date : | April 20, 2017 |
Actual Study Completion Date : | March 26, 2019 |

- Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy [ Time Frame: one month ]
- Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy [ Time Frame: 3 months ]
- Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy [ Time Frame: 6 months ]
- Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy [ Time Frame: 12 months ]
- Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy [ Time Frame: 24 months ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients with a cardiac transplant at the time of inclusion
- Patients transplanted for less than 10 years and having an annual follow-up
- Patients with a biopsy evaluation during their follow-up, at month 1, 3, 6, 12 (newly transplanted) and annually (newly and already transplanted patients) and concomitant routine blood work
- Patients not opposed to the study
- Patients with assessment of anti-donor specific antibodies during the study period
Exclusion Criteria:
- Patients with a multi-organ transplantation

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): NCT02672683
France | |
PARCC/ INSERM U970, Team 4, Xavier Jouven, Cardiovascular epidemiology and sudden death, Georges Pompidou European Hospital, | |
Paris, France, 75015 |
Principal Investigator: | Jean-paul Duong Van Huyen, MD, PhD | Necker Hospital, AP-HP |
Publications:
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT02672683 |
Other Study ID Numbers: |
AOR 14086 |
First Posted: | February 3, 2016 Key Record Dates |
Last Update Posted: | April 19, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |