Study of the Effect of the Benfluorex

NCT02008552 | Completed DMC

• 1 other identifier: MEDIAGENE
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Blood Sample

Keywords

Genetic factor; Valvulopathy; Mediator

Outcome Measures

Primary Outcomes (1)

• Identify the genetic factors

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

  12 months

Secondary Outcomes (1)

• Compare the quality of life

  12 months

Study Arms (1)

Mediagene

OTHER

Sampling blood

Genetic: Sampling of blood

Interventions

Sampling of blood GENETIC

Sampling of blood was taken and analyse to research factor genetic

Mediagene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .
• 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

You may not qualify if:

• 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.
• \- Individual having explicitly refused to participate in the study.

Sponsors & Collaborators

• University Hospital, Brest: lead
• Ministry of Health, France: collaborator

Study Sites (7)

Hôpital Sud Amiens

Amiens, 80054, France

Location

CHRU de Brest

Brest, 29200, France

Location

CHU de la Côte de Nacre Caen

Caen, 14033, France

Location

Hôpital Saint Philibert

Lomme, 59462, France

Location

Hôpital La Timone Marseille

Marseille, 13385, France

Location

Institut du Thorax Nantes

Nantes, 44093, France

Location

Faculté de médecine Toulouse

Toulouse, 31073, France

Location

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Irène Frachon, PH

  CHRU de Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 11, 2013
• Study Start: October 18, 2013
• Primary Completion: October 18, 2021
• Study Completion: October 18, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Locations

FR (7)