Familial HypercholesterolemiaFH CareNCT02013713
French Observatory of Familial Hypercholesterolemia in Cardiology
An observational study of Familial Hypercholesterolemia, run by French Cardiology Society at 1 site in France.
Trial summary
The Family Hypercholesterolemia remains poorly diagnosed disease with an outlet sometimes suboptimal care. However, the Family Hypercholesterolemia exposes patients concerned at increased cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Familial Hypercholesterolemia
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Dec 2016
- Phase
- Observational
- 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
Study population: The study is proposed to cardiology services hospitals. Aged 18 or more, seen in cardiology (USIC, Hospitalization, Consultation), who agreed to participate in the observatory, and coronary patients who have LDL-c levels
Who may be able to join
- coronary patients
- who agreed to participate
- high LDL-c levels: * LDL-c> = 1.9g / l without lipid lowering treatment according to the diagnostic score of Family Hypercholesterolemia these coronary patients with LDL> 1.9g / l may possibly or probably be achieved Hypercholesterolemia Family.
- or
- LDL-c> = 1.6g / l in lipid-lowering treatment, the reduction of LDL-c average expected under standard lipid-lowering therapy (statin alone) being 30-40% of these patients had therefore pretreatment levels greater than 2 g / l or greater than 2.5 g / l and may possibly or probably be achieved Family Hypercholesterolemia after the diagnostic score.
Who cannot join
- Expressed refusal to participate in the observatory
- Age ≤ 18
Trial locations and contacts
1 site in 1 country.
About this study
The Family Hypercholesterolemia remains poorly diagnosed disease with an outlet sometimes suboptimal care. However, the Family Hypercholesterolemia exposes patients concerned at increased cardiovascular risk.
The frequency of familial hypercholesterolemia in cardiologic is little studied and remains unknown, and there is little data on the profile of patients, diagnostic methods and management.
Main objectives:
- Establish a monitoring patients with hypercholesterolemia Family cardiology in France
- Characterize the Family hypercholesterolemia in cardiology, including assessing the frequency of the most severe forms, which are at higher cardiovascular risk.
- Conditions
- Familial Hypercholesterolemia
- Keywords
- Cardiology, Family Hypercholesterolemia
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Family Hypercholesterolemia in cardiology | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of the Family Hypercholesterolemia in cardiology
Number of Family Hypercholesterolemia among patients with LDL-C> 1.9g / l without hypoglycemic treatment or> 1.6g / l in lipid-lowering therapy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startNov 2014
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013713
- Sponsor's protocol ID
- 12 449
- Acronym
- FH Care
- Status last verified
- Aug 2019
- First submitted
- 6 Dec 2013
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Civeira F; International Panel on Management of Familial Hypercholesterolemia. Guidelines for the diagnosis and management of heterozygous familial hypercholesterolemia. Atherosclerosis. 2004 Mar;173(1):55-68. doi: 10.1016/j.atherosclerosis.2003.11.010.
PubMed 15177124
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Observatory of Familial Hypercholesterolemia in Cardiology
- ClinicalTrials.gov ID
- NCT02013713
- Acronym / sponsor ID
- FH Care / 12 449
- Conditions
- Familial Hypercholesterolemia
- Keywords
- Cardiology, Family Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 31 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 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.
The Family Hypercholesterolemia remains poorly diagnosed disease with an outlet sometimes suboptimal care. However, the Family Hypercholesterolemia exposes patients concerned at increased cardiovascular risk.
The frequency of familial hypercholesterolemia in cardiologic is little studied and remains unknown, and there is little data on the profile of patients, diagnostic methods and management.
Main objectives:
- Establish a monitoring patients with hypercholesterolemia Family cardiology in France
- Characterize the Family hypercholesterolemia in cardiology, including assessing the frequency of the most severe forms, which are at higher cardiovascular risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family Hypercholesterolemia in cardiology | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is proposed to cardiology services hospitals. Aged 18 or more, seen in cardiology (USIC, Hospitalization, Consultation), who agreed to participate in the observatory, and coronary patients who have LDL-c levels
Key inclusion criteria (5 listed)
- coronary patients
- who agreed to participate
- high LDL-c levels: * LDL-c> = 1.9g / l without lipid lowering treatment according to the diagnostic score of Family Hypercholesterolemia these coronary patients with LDL> 1.9g / l may possibly or probably be achieved Hypercholesterolemia Family.
- or
- LDL-c> = 1.6g / l in lipid-lowering treatment, the reduction of LDL-c average expected under standard lipid-lowering therapy (statin alone) being 30-40% of these patients had therefore pretreatment levels greater than 2 g / l or greater than 2.5 g / l and may possibly or probably be achieved Family Hypercholesterolemia after the diagnostic score.
Key exclusion criteria (2 listed)
- Expressed refusal to participate in the observatory
- Age ≤ 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of the Family Hypercholesterolemia in cardiology
Time frame: 1 day
Number of Family Hypercholesterolemia among patients with LDL-C> 1.9g / l without hypoglycemic treatment or> 1.6g / l in lipid-lowering therapy
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 15177124Civeira F; International Panel on Management of Familial Hypercholesterolemia. Guidelines for the diagnosis and management of heterozygous familial hypercholesterolemia. Atherosclerosis. 2004 Mar;173(1):55-68. doi: 10.1016/j.atherosclerosis.2003.11.010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Hypercholesterolemia, run by French Cardiology Society at 1 site 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
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?
Frequency of the Family Hypercholesterolemia in cardiology (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02013713, which also lists 1 linked publication.
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 7 Aug 2019.