Registry for Familial Hypercholesterolemia in Russia
Official title: Prospective Russian Study Evaluating the Extent of Underdiagnosed and Undertreated of Familial Hypercholesterolaemia in the Population
Run by Russian Cardiology Research and Production Center · NCT02208869 · Data updated 2026-11-12
This study is testing how common Familial Hypercholesterolemia is in Russia by screening 18,000 people for high cholesterol levels to help improve diagnosis and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 7 Years to 80 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Russian Cardiology Research and Production Center Academic / other |
| Locations | 5 sites (Chelyabinsk and 4 other locations) |
| Status | Recruiting |
| Started | January 2014 |
| Main results expected | December 31, 2017 |
| Study ends | December 31, 2026 |
| Registry record updated | November 2, 2022 |
| Trial ID | NCT02208869 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with total cholesterol levels of 7.5 mmol/L or higher, or LDL-C levels of 4.9 mmol/L or higher, who may have a genetic mutation associated with FH.
✕Probably not a fit
Patients with uncontrolled primary hypothyroidism, nephrotic syndrome, or uncontrolled diabetes mellitus may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the prevalence of Familial Hypercholesterolemia (FH) in the Russian Federation, which is currently underdiagnosed and undertreated. A random sample of 18,000 individuals from Moscow will be screened for total cholesterol and low-density lipoprotein levels, with a focus on identifying those with cholesterol levels indicative of FH. Participants will undergo clinical examinations and genetic testing to better understand the condition and develop optimal treatment strategies. The findings will contribute to reducing cardiovascular risks associated with atherosclerosis in the population.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment of Familial Hypercholesterolemia, ultimately reducing cardiovascular risks for patients.
How similar studies have gone: Other studies have shown success in identifying and treating FH, but this specific registry approach in Russia is novel and aims to fill a significant knowledge gap.
Who can join: the full rules
Show full inclusion / exclusion criteria
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%)
Where it's running
-
EI Chazov National Medical Research Center of Cardiology
Moscow, Russia Recruiting -
Chelyabinsk State Medical Academy
Chelyabinsk, Russia Not yet recruiting -
Novosibirsk Research Institute of Internal Medicine, Institute of Internal Medicine Siberian Branch of the Russian Academy of Medical Sciences
Novosibirsk, Russia Not yet recruiting -
Saint-Petersburg State University and North-West State Medical University n.a. I.I.Mechnikov
Saint Petersburg, Russia Not yet recruiting -
Samara State Medical University
Samara, Russia Not yet recruiting
Study contacts
- Principal investigator: Marat Ezhov, MD, DMSc — Russian Cardiology Research and Production Center
- Study coordinator: Marat Ezhov, MD, PhD
- Email: Marat_Ezhov@mail.ru
- Phone: +79104137499
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
ORIGIN-FH: Newborn screening to detect familial high cholesterol
This project will test a genetic cheek swab of parents plus blood screening of newborns to find familial high cholesterol in babies born to parents with familial hypercholesterolemia.
-
Registry for hereditary cardiovascular diseases in Brazil
This study is trying to create a registry of Brazilian patients with hereditary heart diseases to see how common certain genetic changes are in people with these conditions.
-
Exploring YOLT-101 for treating Familial Hypercholesterolemia
This study is testing a new treatment called YOLT-101 to see if it can safely lower cholesterol levels in people with familial hypercholesterolemia.
-
Atlantic program to optimize cholesterol-lowering care
This program will try coordinated outreach with primary care providers to lower LDL-C in people with familial hypercholesterolemia or LDL-C ≥160 mg/dL.
-
Observational study on genetic lipid disorders in Italy
This study looks at families with high cholesterol to see how genetics affect their condition and treatment, using information gathered during regular doctor visits.
-
Improving detection of familial hypercholesterolemia through lab comments on cholesterol levels
This study is testing if adding helpful comments about high cholesterol levels in lab reports can lead to more people being referred for familial hypercholesterolemia diagnosis and treatment in Southern Denmark.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.