Registry for Familial Hypercholesterolemia in Russia
Prospective Russian Study Evaluating the Extent of Underdiagnosed and Undertreated of Familial Hypercholesterolaemia in the Population
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 7 Years to 80 Years |
| Sex | All |
| Sponsor | Russian Cardiology Research and Production Center Academic / other |
| Locations | 5 sites (Chelyabinsk and 4 other locations) |
| Trial ID | NCT02208869 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with uncontrolled primary hypothyroidism, nephrotic syndrome, or uncontrolled diabetes mellitus may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chelyabinsk and 4 other locations
- Chelyabinsk State Medical Academy — Chelyabinsk, Russia (Not_yet_recruiting)
- EI Chazov National Medical Research Center of Cardiology — Moscow, Russia (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.