Actively Recruiting

Age: 7Years - 80Years
All Genders
NCT02208869

Russian Familial Hypercholesterolemia Registry

Led by Russian Cardiology Research and Production Center · Updated on 2022-11-02

1000

Participants Needed

5

Research Sites

678 weeks

Total Duration

On this page

Sponsors

R

Russian Cardiology Research and Production Center

Lead Sponsor

P

Pfizer

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Russian Familial Hypercholesterolemia Registry

Who Can Participate

Age: 7Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Total cholesterol of 7.5 mmol/L or higher or LDL cholesterol of 4.9 mmol/L or higher before treatment
  • Familial hypercholesterolemia confirmed by mutation in LDL receptor, ApoB gene, or PCSK9 gene
  • Clinical diagnosis of heterozygous FH according to Dutch Lipid Network or Simon Broome Criteria
  • Patients with genetic mutation causing FH
Not Eligible

You will not qualify if you...

  • Uncontrolled primary hypothyroidism with thyroid stimulating hormone above 1.5 times upper normal limit
  • Nephrotic syndrome or kidney dysfunction with serum creatinine above 2.0 mg/dL or creatinine clearance below 15 ml/min
  • Uncontrolled diabetes mellitus with glycated hemoglobin above 8.5%

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Chelyabinsk State Medical Academy

Chelyabinsk, Russia, 454092

Not Yet Recruiting

2

EI Chazov National Medical Research Center of Cardiology

Moscow, Russia, 121552

Actively Recruiting

3

Novosibirsk Research Institute of Internal Medicine, Institute of Internal Medicine Siberian Branch of the Russian Academy of Medical Sciences

Novosibirsk, Russia, 630089

Not Yet Recruiting

4

Saint-Petersburg State University and North-West State Medical University n.a. I.I.Mechnikov

Saint Petersburg, Russia

Not Yet Recruiting

5

Samara State Medical University

Samara, Russia, 443099

Not Yet Recruiting

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Research Team

M

Marat Ezhov, MD, PhD

CONTACT

I

Igor Sergienko, MD, DMSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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