Blood SampleMEDIAGENENCT02008552
Study of the Effect of the Benfluorex
A study testing Sampling of blood in people with Blood Sample, run by University Hospital, Brest at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Sample
- What is being tested?
- Sampling of blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 7 sitesFrance
- Study dates
- 18 Oct 2013to 18 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
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- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Hôpital Sud Amiens
Amiens, 80054
CHRU de Brest
Brest, 29200
CHU de la Côte de Nacre Caen
Caen, 14033
Hôpital Saint Philibert
Lomme, 59462
Hôpital La Timone Marseille
Marseille, 13385
Institut du Thorax Nantes
Nantes, 44093
Faculté de médecine Toulouse
Toulouse, 31073
About this study
Official title: Research for Genetic Factors Involved in the Individual Susceptibility to Develop a Valvulopathy During a Medicinal Exposure in 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.
- Conditions
- Blood Sample
- Being tested
- Sampling of blood
- Keywords
- Genetic factor, Valvulopathy, Mediator
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling of bloodGenetic
Sampling of blood was taken and analyse to research factor genetic
| Study group | Role | What they receive |
|---|---|---|
| Mediagene | Other | Sampling blood Receives: Genetic: Sampling of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the genetic factors
Identify the genetic factors involved in the individual susceptibility to develop a valvulopathy during a medicinal exposure in the benfluorex.
Measured: 12 months
Secondary outcomes (1)
Compare the quality of life
Compare the quality of life of the cases and the witnesses via the completion of Two validated questionnaires of quality of life.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study start18 Oct 2013
- Primary completion18 Oct 2021
- Study completion18 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood SampleStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Irène Frachon, PH, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008552
- Sponsor's protocol ID
- MEDIAGENE
- Acronym
- MEDIAGENE
- Status last verified
- Dec 2021
- First submitted
- 28 Nov 2013
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research for Genetic Factors Involved in the Individual Susceptibility to Develop a Valvulopathy During a Medicinal Exposure in the Benfluorex.
- ClinicalTrials.gov ID
- NCT02008552
- Acronym / sponsor ID
- MEDIAGENE / MEDIAGENE
- Conditions
- Blood Sample
- Keywords
- Genetic factor, Valvulopathy, Mediator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 18 Oct 2013 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mediagene | Other | Genetic: Sampling of bloodSampling blood |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampling of bloodSampling of blood was taken and analyse to research factor genetic | Genetic | Mediagene |
Primary outcome
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.
1 secondary outcome
Compare the quality of life
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irène Frachon, PH principal investigator
CHRU de Brest
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampling of blood in people with Blood Sample, run by University Hospital, Brest at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the genetic factors (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.