Prospective Russian Study Evaluating the Extent of Underdiagnosed and Undertreated of Familial Hypercholesterolaemia in the Population

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Chelyabinsk State Medical Academy
NOT_YET_RECRUITING
Chelyabinsk
EI Chazov National Medical Research Center of Cardiology
RECRUITING
Moscow
Novosibirsk Research Institute of Internal Medicine, Institute of Internal Medicine Siberian Branch of the Russian Academy of Medical Sciences
NOT_YET_RECRUITING
Novosibirsk
Saint-Petersburg State University and North-West State Medical University n.a. I.I.Mechnikov
NOT_YET_RECRUITING
Saint Petersburg
Samara State Medical University
NOT_YET_RECRUITING
Samara
Contact Information
Primary
Marat Ezhov, MD, PhD
Marat_Ezhov@mail.ru
+79104137499
Backup
Igor Sergienko, MD, DMSc
igorcardio@mail.ru
+79031492253
Time Frame
Start Date: 2014-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 1000
Treatments
Patients diagnosed with FH
Subjects of both sexes above the age of 18 with TC ≥7.5 mmol/L or LDL-C ≥4.9 mmol/L will be included in the Program. Clinical diagnosis of FH will be established using both the Dutch and the British criteria.~Those with secondary causes of hypercholesterolemia, such as untreated diabetes mellitus (HbA1c \>8%) or hypothyroidism (thyroid-stimulating hormone \>1.5 upper normal limit), renal failure (creatinine clearance \<30 ml/min), holestatic liver diseases, including biliary cirrhosis, tumors with an active process in the last 5 years will be excluded from the study.
Sponsors
Collaborators: Amgen, Pfizer, AstraZeneca
Leads: Russian Cardiology Research and Production Center

This content was sourced from clinicaltrials.gov