Genetic Testing and Motivational Counseling for FH

  • STATUS
    Recruiting
  • End date
    Oct 31, 2022
  • participants needed
    180
  • sponsor
    National Medical Research Center for Therapy and Preventive Medicine
Updated on 1 November 2021
atorvastatin
statin
ezetimibe
lipid-lowering therapy
cholesterol level
genetic analysis
evolocumab
pcsk9

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.

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.

Details
Condition genetic test, Psychological Counseling, Broad Beta Disease, genetic analysis, Hypercholesterolemia, Familial, 3, Compliance, Hypercholesterolemia, Familial, Due to Ligand-Defective Apolipoprotein B, Familial Hypercholesterolemia, Hypercholesterolemia Familial Due to Genetic Defect of Apolipoprotein B, Cascade Screening, Hypercholesterolemia, Familial, 1, Therapeutic Adherence and Compliance, Noncompliance with medication regimen, motivational enhancement therapy, Familial Hypercholesterolemia - Heterozygous, Hypercholesterolemia, Familial, 4, Autosomal Recessive, Treatment Adherence and Compliance, Familial Hypercholesterolemia Due to Heterozygous LDL Receptor Mutation, genetic tests, Hypercholesterolemia, Familial, 4, Treatment Adherence, Patient Compliance, Therapeutic Adherence, FAMILIAL HYPERCHOLESTEROLEMIA, Hypercholesterolemia, Autosomal Dominant, 3, Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B, Fredrickson Type III Hyperlipoproteinemia, Hypercholesterolemia, Familial, 2, Motivational Interviewing, Adherence, Genetic Testing
Treatment genetic testing, Motivational Counseling, Visit 1, Visit 2, Lipid analysis, Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet), Visit 3
Clinical Study IdentifierNCT04656028
SponsorNational Medical Research Center for Therapy and Preventive Medicine
Last Modified on1 November 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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