Genetic Testing and Motivational Counseling for FH (GENMOTIV-FH)

  • STATUS
    Recruiting
  • End date
    May 31, 2024
  • participants needed
    180
  • sponsor
    National Medical Research Center for Therapy and Preventive Medicine
Updated on 4 October 2022
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 Hypercholesterolemia, Familial, Hypercholesterolemia, Familial, 1, Hypercholesterolemia, Familial, 2, Hypercholesterolemia, Familial, 3, Hypercholesterolemia, Familial, 4, Hypercholesterolemia, Familial, 4, Autosomal Recessive, Familial Hypercholesterolemia With Hyperlipemia, Hypercholesterolemia, Autosomal Dominant, Type B, Hypercholesterolemia, Autosomal Dominant, Hypercholesterolemia, Autosomal Dominant, 3, Apolipoprotein B-100, Familial Defective, Genetic Testing, Motivational Interviewing, Therapeutic Adherence, Therapeutic Adherence and Compliance, Treatment Adherence, Medication Adherence, Treatment Adherence and Compliance, Patient Adherence, Compliance, Patient Compliance, Familial Hypercholesterolemia, Familial Hypercholesterolemia - Heterozygous, Adherence, Patient, Adherence, Medication, Adherence
Treatment genetic testing, Motivational Counseling, Visit 1, Visit 2, Lipid analysis, Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet), Visit 3, Visit 4
Clinical Study IdentifierNCT04656028
SponsorNational Medical Research Center for Therapy and Preventive Medicine
Last Modified on4 October 2022

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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