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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediagene | Other | Sampling blood |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sampling of blood | Genetic | Sampling of blood was taken and analyse to research factor genetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria of the cases :
Inclusion criteria of witnesses :
Exclusion criteria of the cases:
Exclusion criteria of witnesses :
- Individual having explicitly refused to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Irène Frachon, PH | CHRU de Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Sud Amiens | Amiens | 80054 | France | |||
| CHRU de Brest |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |