Status:
RECRUITING
Russian Familial Hypercholesterolemia Registry
Lead Sponsor:
Russian Cardiology Research and Production Center
Collaborating Sponsors:
Pfizer
Amgen
Conditions:
Familial Hypercholesterolemia
Eligibility:
All Genders
7-80 years
Brief 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 algor...
Detailed Description
\*Design. We have chosen a randomly selected cohort of individuals who have been tested in the Moscow office of the "INVITRO" Laboratory on the basis of advertising campaign held in September, 2013, f...
Eligibility Criteria
Inclusion
- 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
- 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%)
Key Trial Info
Start Date :
January 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT02208869
Start Date
January 1 2014
End Date
December 31 2026
Last Update
November 2 2022
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Chelyabinsk State Medical Academy
Chelyabinsk, Russia, 454092
2
EI Chazov National Medical Research Center of Cardiology
Moscow, Russia, 121552
3
Novosibirsk Research Institute of Internal Medicine, Institute of Internal Medicine Siberian Branch of the Russian Academy of Medical Sciences
Novosibirsk, Russia, 630089
4
Saint-Petersburg State University and North-West State Medical University n.a. I.I.Mechnikov
Saint Petersburg, Russia