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Non Invasive Detection of Cardiac Allograft Rejection by Circulating microRNAs (MIRRACLE)

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ClinicalTrials.gov Identifier: NCT02672683
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
The purpose of this study is to evaluate the level of expression of 4 circulating microRNAs in the serum using RT-PCR. A pilote study with cardiac transplant patients has shown that expression of these microRNAs could discriminate patients with a histologically proven rejection from patient displaying a normal endomyocardial biopsy. The signature must be confirmed in unselected patients and its stability evaluated according to clinical, biological and immunological parameters of included patients.

Condition or disease
Cardiac Transplantation

Detailed Description:

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 Design
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Study Type : Observational
Estimated Enrollment : 400 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
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 25, 2018

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy [ Time Frame: one month ]
  2. Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy [ Time Frame: 3 months ]
  3. Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy [ Time Frame: 6 months ]
  4. Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy [ Time Frame: 24 months ]

Eligibility Criteria
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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
Study Population
Patients with a cardiac transplant
Criteria

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
Contacts and Locations
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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


Contacts
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Contact: Jean-Paul Duong Van Huyen, MD, PhD +33 1 44 49 49 49 jean-paul.duong@nck.aphp.fr
Contact: valérie Fauroux +33 1 58 41 12 13 valerie.fauroux@aphp.fr

Locations
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France
PARCC/ INSERM U970, Team 4, Xavier Jouven, Cardiovascular epidemiology and sudden death, Georges Pompidou European Hospital, Recruiting
Paris, France, 75015
Contact: Maud RACAPE, PhD    +33 1 53 98 80 25    maud.racape@inserm.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean-paul Duong Van Huyen, MD, PhD Necker Hospital, AP-HP
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02672683     History of Changes
Other Study ID Numbers: AOR 14086
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No