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Russian Familial Hypercholesterolemia Registry

Recruitingn/aAges 7 Years - 80 YearsAllRussian Cardiology Research and Production Center
NCT02208869 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

True prevalence of FH in the Russian Federation is unknown which leads to low percentage of diagnosed and treated cases. Research is needed to determine the prevalence of FH, specific diagnostic algorithms and optimal treatment strategies. The main aim of the present study is to evaluate the extent to which FH is underdiagnosed and undertreated in the Russian Federation for reduction of cardiovascular risk related to atherosclerosis in the country. As a first step, total cholesterol (TC) and low-density lipoprotein (LDL-C) levels will be determined in a random sample from Moscow population (n=18000). It is expected that TC ≥ 7.5 mmol/L will be detected in 10% of cohort. During 2014, approximately 500 patients will pass through non-invasive clinical examination at the Russian Cardiology Research and Production Center, including patient demographics, past medical history, family history o

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📋 Eligibility rules (as published)
Inclusion Criteria: * Total cholesterol ≥7.5 mmol/L or LDL-C ≥4.9 mmol/L (pretreatment levels) * Familial hypercholesterolemia defined as: a. Mutation in the LDL receptor and/or the ApoB gene and/or the PCSK9 gene; or b. clinical diagnosis of heterozygous FH (HeFH) according to the Dutch Lipid Network Criteria or Simon Broom Criteria * Patients with genetic mutation of FH Exclusion Criteria: * uncontrolled primary hypothyroidism (thyroid stimulating hormone (TSH) \>1.5 x upper limit of normal (ULN)), * nephrotic syndrome and/or renal dysfunction (scrum creatinine \>2.0 mg/dL or 160mmol/l, creatinine clearance \<15 ml/min) at screening. * uncontrolled diabetes mellitus (Glycated hemoglobin \>8.5%)
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What it tests

  • Not listed
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Where

5 sites
Chelyabinsk State Medical Academy
Chelyabinsk, Russia
EI Chazov National Medical Research Center of Cardiology
Moscow, Russia
Novosibirsk Research Institute of Internal Medicine, Institute of Internal Medicine Siberian Branch of the Russian Academy of Medical Sciences
Novosibirsk, Russia
Saint-Petersburg State University and North-West State Medical University n.a. I.I.Mechnikov
Saint Petersburg, Russia
Samara State Medical University
Samara, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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