NCT02008552

Completed

Study of the Effect of the Benfluorex

University Hospital, Brest Source

Compare

Other study identifiers

Sponsor study identifier

MEDIAGENE

Study Type

interventional

Actual enrollment (reported)

346

Locations

1 country

Sites

7

Timeline

Study Start

October 18, 2013

Actual (reported)

Primary Completion

October 18, 2021

Actual (reported)

Study Completion

October 18, 2021

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 346 participants
Study completion date: October 18, 2021
Actual (reported)
Listed locations: 1 countries · 7 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 18, 2013
Actual (reported)
First Submitted
November 28, 2013
Actual (reported)
First Posted
December 11, 2013
Actual (reported)
Primary Completion
October 18, 2021
Actual (reported)
Study Completion
October 18, 2021
Actual (reported)

Last Updated: December 21, 2021
Status Verified: December 2021
Last Update Submitted: December 16, 2021

Conditions

Blood Sample

Keywords

Genetic factorValvulopathyMediator

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 bloodGenetic

Sampling of blood was taken and analyse to research factor genetic

Mediagene

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Ministry of Health, France
Governmentcollaborator
University Hospital, Brest
Otherlead

Study Sites (7)

Hôpital Sud Amiens

Amiens, 80054, France

CHRU de Brest

Brest, 29200, France

CHU de la Côte de Nacre Caen

Caen, 14033, France

Hôpital Saint Philibert

Lomme, 59462, France

Hôpital La Timone Marseille

Marseille, 13385, France

Institut du Thorax Nantes

Nantes, 44093, France

Faculté de médecine Toulouse

Toulouse, 31073, France

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

Irène Frachon, PH
CHRU de Brest
PRINCIPAL INVESTIGATOR

Enrollment

346 participants (actual enrollment reported by the registry).

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

Actual (reported)

Completed

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Not ApplicableRecruiting

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.

Contact the study team to confirm eligibility.

Primary Completion

October 18, 2021

Actual (reported)

Study Completion

October 18, 2021

Actual (reported)

Last Updated

December 21, 2021

Record last verified: 2021-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02008552
Data provider: ClinicalTrials.gov
Source updated: 2021-12-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:46 UTC

Locations

FR(7)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Mediagene

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations