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Greek Registry - Familial Hypercholesterolaemia (GRegistry-FH)

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ClinicalTrials.gov Identifier: NCT03140605
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Genovefa Kolovou, M.D., Ph.D., F.E.S.C., S.F.S.A, Hellenic College of Treatment of Atherosclerosis

Brief Summary:
Familial hypercholesterolemia (FH) [heterozygous (heFH) or homozygous FH (hoFH)] is a common genetic disorder, characterized by elevated plasma low density lipoprotein (LDL) cholesterol concentration leading (if untreated) to cholesterol deposits in the corneas, eyelids and extensor tendons, rapidly progressing vascular disease, and aortic valve disease.

Condition or disease
Familial Hypercholesterolemia

Detailed Description:

In contrast, timely recognition and effective treatment of FH can result in a significant improvement in clinical outcomes. The problem is that that majority of individuals with FH are unaware of their disease, particularly that the disease remains silent for many years. In most countries around the world <5% of individuals with FH are identified .

Until lately the prevalence of heFH was traditionally considered to be ~ 1:500 individuals , although clinical and genetic studies suggest that heFH affects ~ 1:200-250 individuals . Thus, the aim of the Hellenic College of Treatment of Atherosclerosis (HCAT) is to 1). Evaluate the prevalence of FH in Greece (FHG-Registry) and 2). To inform population of FH disease.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Hellenic Registry for Familial Hypercholesterolemia
Actual Study Start Date : January 10, 2017
Estimated Primary Completion Date : January 10, 2019
Estimated Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. the prevalence of Familiar Hypercholesterolaemia in Greece [ Time Frame: 1 month ]
    patients with FH will be screened and include in Registry



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sample of citizents on Panhellenic basis
Criteria

Inclusion Criteria:

  • both genders
  • >18 years, <80 years
  • door to door enrolment
  • eligible to sign informed consent

Exclusion Criteria:

  • <18 years, >80 years
  • deny to sign informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140605


Contacts
Contact: Genovefa Kolovou, MD genovefa@kolovou.com

Locations
Greece
Onassis Cardiology Hospital Recruiting
Athens, Greece
Contact: Genovefa Kolovou, MD         
Sponsors and Collaborators
Hellenic College of Treatment of Atherosclerosis

Publications:
EAS Familial Hypercholesterolaemia Studies Collaboration, Vallejo-Vaz AJ, Akram A, Kondapally Seshasai SR, Cole D, Watts GF, Hovingh GK, Kastelein JJ, Mata P, Raal FJ, Santos RD, Soran H, Freiberger T, Abifadel M, Aguilar-Salinas CA, Alnouri F, Alonso R, Al-Rasadi K, Banach M, Bogsrud MP, Bourbon M, Bruckert E, Car J, Ceska R, Corral P, Descamps O, Dieplinger H, Do CT, Durst R, Ezhov MV, Fras Z, Gaita D, Gaspar IM, Genest J, Harada-Shiba M, Jiang L, Kayikcioglu M, Lam CS, Latkovskis G, Laufs U, Liberopoulos E, Lin J, Lin N, Maher V, Majano N, Marais AD, März W, Mirrakhimov E, Miserez AR, Mitchenko O, Nawawi H, Nilsson L, Nordestgaard BG, Paragh G, Petrulioniene Z, Pojskic B, Reiner Ž, Sahebkar A, Santos LE, Schunkert H, Shehab A, Slimane MN, Stoll M, Su TC, Susekov A, Tilney M, Tomlinson B, Tselepis AD, Vohnout B, Widén E, Yamashita S, Catapano AL, Ray KK. Pooling and expanding registries of familial hypercholesterolaemia to assess gaps in care and improve disease management and outcomes: Rationale and design of the global EAS Familial Hypercholesterolaemia Studies Collaboration. Atheroscler Suppl. 2016 Dec;22:1-32. doi: 10.1016/j.atherosclerosissup.2016.10.001. Epub 2016 Dec 7.

Responsible Party: Genovefa Kolovou, M.D., Ph.D., F.E.S.C., S.F.S.A, Cardiologist, Head of Hellenic College of Treatment of Atherosclerosis, Hellenic College of Treatment of Atherosclerosis
ClinicalTrials.gov Identifier: NCT03140605     History of Changes
Other Study ID Numbers: 2017-HPLS-IIS
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias