Skip to main content
OpenTrials
Completed

NCT Number: NCT02008552

Study of the Effect of the Benfluorex

More than 5 million persons in France exposed, in last years, to the taking of the Benfluorex.

Arisen, at certain patients, of a valvulopathy characterized by mitrals and/or aortic leaks Withdrawal of the French market: nov. 2009 Only a percentage limited by exposed patients developed a severe valvulopathy (1/1000), whereas on the contrary, many patients were exposed during years without developing the slightest anomaly.

The hypothesis is the existence of a particular genetic susceptibility at the patients having developed a valvulopathy continuation in the exposure in this medicine.

Existence of one varying genetics with strong effect. The purpose is to identify involved genetic factors.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Sud Amiens, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

of the cases :

  • Individual presenting a typical medicinal valvulopathy defined by:
  • A previous exposure of at least 6 months in the benfluorex or occasional exposure accepted about is the posology. The preliminary exposure in the dexfenfluramine or in the fenfluramine is authorized.
  • A picture board of insufficiency mitral restrictive and/or aortic restrictive (in echocardiography) typical of a medicinal achievement, a gravity (rank I - IV), without cause associated of valvulopathy with compatible macroscopic and histological aspect (for the operated patients).
  • Individual followed in one of the sites of study or recruited via associations AVIM and CADUS.
  • Individual of Caucasian origin
  • Individual having signed the form of specific consent for the study individual .

Inclusion criteria

of witnesses :

  • Individual presenting an exposure previous to the benfluorex superior or equal to the equivalent of 2 years of treatment in 3 tablets a day and pursued to 2 years preceding the realization of a cardiac echography of screening. The preliminary exposure in the dexfenfluramine or in the fenfluramine is authorized.
  • Individual presenting a strictly normal cardiac echography in particular: absence of valvulopathy significant, of morphological valvular anomaly (event without echography) and of valvular, including "trivial" leak at the aortic level. The mitrals micro leaks "physiological" are accepted.
  • Individual having been seen for screening in one of the sites of study or in in French firms cardilogie which cardiologists are members of the French Society of Cardiologyor or via the law firms of the civil parties or having been included in the forward-looking study coordinated by Pr. TRIBOUILLOY (which the objective is to compare the echography data of a group of patients having been treated at least 3 months in the benfluorex and with a group of patients diabetics having never received this medicine).
  • Individual of Caucasian origin.
  • Individual having signed the form of specific consent for the study

Exclusion criteria

of the cases:

  • Individual presenting another associated heart disorder.
  • Individual having been exposed to another agonists of the receivers 5-HT2B such as the pergolide, the cabergoline, the lisuride, the quibbled by-products or the ecstasy.
  • Individual having explicitly refused to participate in the study.

Exclusion criteria

of witnesses :

  • Individual having explicitly refused to participate in the study.

Treatment and study plan

Sampling of blood

Genetic

Sampling of blood was taken and analyse to research factor genetic

Primary outcomes

  1. Identify the genetic factors

    Time frame: 12 months

    Identify the genetic factors involved in the individual susceptibility to develop a valvulopathy during a medicinal exposure in the benfluorex.

Secondary outcomes

  1. Compare the quality of life

    Time frame: 12 months

    Compare the quality of life of the cases and the witnesses via the completion of Two validated questionnaires of quality of life.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Research for Genetic Factors Involved in the Individual Susceptibility to Develop a Valvulopathy During a Medicinal Exposure in the Benfluorex.

Acronym: MEDIAGENE

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2013
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.