Non Invasive Detection of Cardiac Allograft Rejection by Circulating microRNAs

NCT02672683 | Completed

• 1 other identifier: AOR 14086
• Study Type: observational
• Target: 461
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Transplantation

Outcome Measures

Primary Outcomes (4)

• Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy

  one month

• Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy

  3 months

• Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy

  6 months

• Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy

  12 months

Secondary Outcomes (1)

• Comparison of circulating MicroRNAs measurement in serum with histopathological diagnosis of rejection on concomitant endomyocardial biopsy

  24 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a cardiac transplant

You may qualify if:

• 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

You may not qualify if:

• Patients with a multi-organ transplantation

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

PARCC/ INSERM U970, Team 4, Xavier Jouven, Cardiovascular epidemiology and sudden death, Georges Pompidou European Hospital,

Paris, 75015, France

Location

Related Publications (2)

• Duong Van Huyen JP, Tible M, Gay A, Guillemain R, Aubert O, Varnous S, Iserin F, Rouvier P, Francois A, Vernerey D, Loyer X, Leprince P, Empana JP, Bruneval P, Loupy A, Jouven X. MicroRNAs as non-invasive biomarkers of heart transplant rejection. Eur Heart J. 2014 Dec 1;35(45):3194-202. doi: 10.1093/eurheartj/ehu346. Epub 2014 Aug 31.

  PMID: 25176944 BACKGROUND

• Coutance G, Racape M, Baudry G, Lecuyer L, Roubille F, Blanchart K, Epailly E, Vermes E, Pattier S, Boignard A, Gay A, Bruneval P, Jouven X, Duong Van Huyen JP, Loupy A. Validation of the clinical utility of microRNA as noninvasive biomarkers of cardiac allograft rejection: A prospective longitudinal multicenter study. J Heart Lung Transplant. 2023 Nov;42(11):1505-1509. doi: 10.1016/j.healun.2023.07.010. Epub 2023 Jul 23.

  PMID: 37487804 RESULT

Study Officials

• Jean-paul Duong Van Huyen, MD, PhD

  Necker Hospital, AP-HP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: February 3, 2016
• Study Start: September 26, 2016
• Primary Completion: April 20, 2017
• Study Completion: March 26, 2019
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)