Active — Not RecruitingNot Applicable

Genetic Testing and Motivational Counseling for FH

Russia180 participantsStarted 2020-06-15

Plain-language summary

To date, there are highly effective lipid-lowering drugs, the combination of which makes it possible to achieve the target level of LDL-C in most patients with familial hypercholesterolemia (FH). However, the effectiveness of treatment of FH patients strongly depends on adherence to lipid-lowering therapy and to the healthy lifestyle, as well as the detection of the disease and the therapy prescription as early as possible, better in childhood. The aim of the study is to assess the impact of genetic testing and motivational counseling on the effectiveness of treatment and cascade screening in patients with FH.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Probable or definite diagnosis of FH according to the Dutch criteria (6 points or more); * Signed informed consent; Exclusion Criteria: * Pregnancy or lactation at the time of enrollment * Established active severe infectious disease or severe hematologic, metabolic, gastrointestinal or endocrine dysfunctions (for example, uncontrolled thyroid dysfunction or uncontrolled diabetes mellitus) in the opinion of the investigator * Active liver disease * Estimated GFR≤ 30 ml / min / 1.73m2 * Any other conditions at Visit 1 that, according to the investigator's opinion, render the patient ineligible for inclusion in the study, may interfere with the patient's participation in the study or patient's completion of the study.

What they're measuring

Change in the proportion of people who have reached the target level of LDL-Cholesterol

Timeframe: 3 months

Change in the number of relatives who underwent cascade screening

Timeframe: 3 months

Change in the proportion of people adhering to drug therapy

Timeframe: 3 months

Change in the proportion of people adhering to the recommended physical activity

Timeframe: 3 months

Change in the proportion of individuals adhering to the recommended dietary recommendations

Timeframe: 3 months

Trial details

NCT IDNCT04656028

SponsorNational Medical Research Center for Therapy and Preventive Medicine

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-01-30

View on ClinicalTrials.gov More Hypercholesterolemia, Familial trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in the proportion of people who have reached the target level of LDL-Cholesterol

Timeframe: 3 months

Change in the number of relatives who underwent cascade screening

Timeframe: 3 months

Change in the proportion of people adhering to drug therapy

Timeframe: 3 months

Change in the proportion of people adhering to the recommended physical activity

Timeframe: 3 months

Change in the proportion of individuals adhering to the recommended dietary recommendations

Timeframe: 3 months