Russian Familial Hypercholesterolemia Registry

NCT02208869 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2022-11-02

No results posted yet for this study

Summary

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 of hypercholesterolemia, physical findings, current lipid-lowering therapies, blood tests, genetic analysis, echocardiography, carotid duplex ultrasound and exercise SPECT imaging in selected cases. On the basis of the Moscow Program four major Federal Medical Centers will be involved, and FH Registry will be created as a national, multi-center initiative to screen FH patients, control their diagnosis and management, and track clinical-reported outcomes over time.

Establishment of National Guidelines for the diagnosis and treatment of FH on the basis of these data and implementation those into clinical practice in different regions of Russia will allow improving patient care. As an expected outcome, this program will raise awareness and increase appropriate assessment and treatment of FH patients in Russia, leading to a timely detection of the disease and therapy initiation.

Conditions

  • Familial Hypercholesterolemia

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY
  • Amgen

    collaborator INDUSTRY
  • AstraZeneca

    collaborator INDUSTRY
  • Russian Cardiology Research and Production Center

    lead OTHER

Principal Investigators

  • Valery Kukharchuk, MD, DMSc · Russian Cardiology Research and Production Center

  • Igor Sergienko, MD, DMSc · Russian Cardiology Research and Production Center

  • Marat Ezhov, MD, DMSc · Russian Cardiology Research and Production Center

Eligibility

Min Age
7 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-12-31
Completion
2026-12-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02208869 on ClinicalTrials.gov