Genetic Testing and Motivational Counseling for FH

Last updated: December 16, 2024
Sponsor: National Medical Research Center for Therapy and Preventive Medicine
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Familial Hypercholesterolemia

Hypercholesterolemia

Dyslipidemia

Treatment

Visit 2

Genetic Testing

Visit 4

Clinical Study ID

NCT04656028
08-03/19
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Probable or definite diagnosis of FH according to the Dutch criteria (6 points ormore);

  • Signed informed consent;

Exclusion

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 thyroiddysfunction 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 thepatient's participation in the study or patient's completion of the study.

Study Design

Total Participants: 180
Treatment Group(s): 8
Primary Treatment: Visit 2
Phase:
Study Start date:
June 15, 2020
Estimated Completion Date:
March 30, 2025

Study Description

There are several tasks of the study:

  1. To assess the effect of knowledge of patients with FH about the result of their FH genetic testing on the adherence to a healthy lifestyle and hypolipidemic therapy.

  2. To assess the impact of knowledge of patients with FH about the result of their FH genetic testing on the effectiveness of cascade screening.

  3. To assess the influence of motivational counseling of patients with FH on the adherence to a healthy lifestyle and hypolipidemic therapy.

  4. To assess the impact of motivational counseling of patients with FH on the effectiveness of cascade screening.

Connect with a study center

  • National Medical Research Centre for Therapy and Preventive Medicine of the Ministry of Health of Russia

    Moscow, 101000
    Russian Federation

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.