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Genetic Testing and Motivational Counseling for FH

Study acronym: GENMOTIV-FH
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 17, 2024 (before its estimated January 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Sep 30, 2024 to Jan 30, 2025
    • Site details revised
    v7
  2. Primary completion date: Jul 31, 2023 to Sep 30, 2024
    • Study completion date: May 31, 2024 to Mar 30, 2025
    v6
  3. Primary completion date: Mar 1, 2023 to Jul 31, 2023v5
  4. Primary completion date: Oct 31, 2022 to Mar 1, 2023
    • Study completion date: Oct 31, 2022 to May 31, 2024
    • Interventions: Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet) (Other), Genetic Testing (Genetic), Lipid analysis… to Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet) (Other), Genetic Testing (Genetic), Lipid analysis…
    • Secondary endpoints expanded, about 58 words
    v4
  5. Primary and study completion dates: Oct 31, 2021 to Oct 31, 2022v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04656028
Lead Sponsor National Medical Research Center for Therapy and Preventive Medicine
Collaborators: Moscow State University of Medicine and Dentistry
Conditions
(from sponsor)		 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 +18 more
Related terms Hypercholesterolemia, Hypercholesterolemia, Autosomal Dominant, 3, Hyperlipoproteinemia Type II, Hyperlipoproteinemia Type III, Medication Adherence, Patient Compliance, Treatment Adherence and Compliance
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov