Russian Familial Hypercholesterolemia Registry

Plain-language summary

This registry collects data on patients with familial hypercholesterolemia, an inherited condition that causes very high cholesterol. Patients with very high cholesterol diagnosed with familial hypercholesterolemia, either by a mutation in the LDL receptor, ApoB, or PCSK9 gene or by clinical criteria, can take part. It is a registry with no assigned phase and is still recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Russian Cardiology Research and Production Center

Start date

1/1/2014

Estimated completion

12/31/2026

Countries

Russia

Related genes

Locations

• Chelyabinsk, Russia
• Moscow, Russia
• Novosibirsk, Russia
• Saint Petersburg, Russia
• Samara, Russia

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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%)