Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555120
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Screening for Familial Hypercholesterolemia in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Screening for Familial Hypercholesterolemia in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYPERCHOF
Brief Summary:
Familial hypercholesterolemia is the most common treatable genetic disorder for which a simple effective treatment is available with few side effects
It leads to a significant increase in LDL levels generally in excess of 19gl including in children It is much higher than the values usually found in secondary or polygenic hypercholesterolemia This condition multiplies the cardiovascular risk in adulthood by a factor of 13 and is responsible for 6500 early cardiovascular events per year In the absence of treatment the state of the arteries of patients with familial hypercholesterolemia at the age of 40 would be equivalent to that of 80-year-olds
Currently the prevalence is estimated at 1 in 300 people in France However this prevalence is largely underestimated as targeted screening is rarely carried out and it is estimated that only 10 of sufferers are diagnosed in France and only 5 of affected children are known and treated
Today according to the French health authority the indications for screening children are a history of an early vascular event in one of the two parents or familial hypercholesterolemia in a first-degree relative
However the World Health Organization and numerous studies recommend extending screening to the general population Screening all children and teenagers could make it possible to introduce healthy dietary habits at an early stage to better adapt the choice of contraception in young women to treat before the first symptoms appear and thus reduce mortality in adulthood by up to 48 and to screen relatives who have not yet had a cardiovascular event
In Slovenia 90 of children have had a lipid panel since 1994 significantly reducing mortality In the United Kingdom the lipid check-up offered as part of a compulsory visit at the age of two is being rolled out 90 of families naturally take it up on the recommendation of their doctors
The treatment of hypercholesterolemia is simple and relies first and foremost on hygienic dietary rules and treatments such as statins and Liptruzet a combination of atorvastatin and ezetimibe treatments that are easily accessible effective with few side effects and low cost
It leads to a significant increase in LDL levels generally in excess of 19gl including in children It is much higher than the values usually found in secondary or polygenic hypercholesterolemia This condition multiplies the cardiovascular risk in adulthood by a factor of 13 and is responsible for 6500 early cardiovascular events per year In the absence of treatment the state of the arteries of patients with familial hypercholesterolemia at the age of 40 would be equivalent to that of 80-year-olds
Currently the prevalence is estimated at 1 in 300 people in France However this prevalence is largely underestimated as targeted screening is rarely carried out and it is estimated that only 10 of sufferers are diagnosed in France and only 5 of affected children are known and treated
Today according to the French health authority the indications for screening children are a history of an early vascular event in one of the two parents or familial hypercholesterolemia in a first-degree relative
However the World Health Organization and numerous studies recommend extending screening to the general population Screening all children and teenagers could make it possible to introduce healthy dietary habits at an early stage to better adapt the choice of contraception in young women to treat before the first symptoms appear and thus reduce mortality in adulthood by up to 48 and to screen relatives who have not yet had a cardiovascular event
In Slovenia 90 of children have had a lipid panel since 1994 significantly reducing mortality In the United Kingdom the lipid check-up offered as part of a compulsory visit at the age of two is being rolled out 90 of families naturally take it up on the recommendation of their doctors
The treatment of hypercholesterolemia is simple and relies first and foremost on hygienic dietary rules and treatments such as statins and Liptruzet a combination of atorvastatin and ezetimibe treatments that are easily accessible effective with few side effects and low cost
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None