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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04656028
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : March 29, 2023
Sponsor:
Collaborator:
Moscow State University of Medicine and Dentistry
Information provided by (Responsible Party):
National Medical Research Center for Therapy and Preventive Medicine

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
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 Genetic: Genetic Testing Behavioral: Motivational Counseling Diagnostic Test: Lipid analysis Other: Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet) Other: Visit 1 Other: Visit 2 Other: Visit 3 Other: Visit 4 Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The trial is a randomized prospective cohort study. The study will include patients 18 years of age and older with a probable or definite diagnosis of FH according to the Dutch criteria (6 points or more). A total of 180 patients will be included in the study. All patients will be randomly divided into 2 groups for genetic testing. Randomization will be performed as block randomization with a 2:1 allocation ratio (2 with genetic testing : 1 without genetic testing). The allocation ratio 2:1 was chosen because in the group with genetic testing there will be cases where mutation(s) associated with FH will be identified and cases where the mutation(s) will not be identified. A separate analysis is planned in patients with genetic testing and identified mutation(s) and in patients with genetic testing but no identified mutation(s).

Each study group will be randomized into 2 subgroups depending on the conduct of motivational counseling with an 1:1 allocation ratio.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Genetic Testing and Motivational Counseling on the Adherence to Healthy Lifestyle and Hypolipidemic Therapy and Efficiency of Cascade Screening in Patients With Familial Hypercholesterolemia (GENMOTIV-FH)
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1 - without genetic testing; subgroup without motivational counseling
Group 1 - without genetic testing; subgroup without motivational counseling
 Diagnostic Test: Lipid analysis
Assessment of total cholesterol, low density lipoproteins, high density lipoproteins, triglycerides, alanine aminotransferase.

Other: Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet)
All patients will be prescribed ezetimibe and statins (atorvastatin / rosuvastatin) at the maximum dosage. If somebody has an intolerance to atorvastatin, the drug will be replaced with rosuvastatin and vice versa. In case of intolerance to all drugs from the statin group, the patient will be prescribed ezetimibe with a PCSK9 inhibitor (alirocumab / evolocumab). After receiving the results of the lipid spectrum, ALT, if necessary, the lipid-lowering therapy may be corrected.

Other: Visit 1

Visit 1: initially (on enrollment) - informed consents signing; lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid-lowering therapy and lifestyle; filling all questionnaires. After this visit patients are randomized to groups with or without genetic testing and then randomized to groups with or without motivational counseling.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform, a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days.


Other: Visit 2

Visit 2 (in 2-3 months): lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid lowering-therapy and lifestyle; filling all questionnaires. Patients from the group with genetic testing will get the result of this genetic testing. Patients from the group with motivational counseling will get two consultations with a psychologist (motivational counseling on lifestyle modification) during Visit 2 and in one month after Visit 2.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days


Other: Visit 3

Visit 3 (in 3 months after Visit 2): lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid-lowering therapy and lifestyle; filling all questionnaires.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days.


Other: Visit 4

Visit 4 (in 12 months after Visit 3): lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid-lowering therapy and lifestyle; filling all questionnaires.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days.
Experimental: Group 1 - without genetic testing; subgroup with motivational counseling
Group 1 - without genetic testing; subgroup with motivational counseling
 Behavioral: Motivational Counseling

Motivational counseling will be carried out during Visit 2 and in one month after Visit 2 by certified psychologist with taking into account the results of the psychodiagnostic survey conducted at the first and second visits.

The goals of motivational counseling:

  1. Increasing motivation for a healthy lifestyle;
  2. Increasing adherence to treatment;
  3. Increased motivation to invite relatives for cascade screening. Motivational counseling will be carried out using methods of motivational interviewing, transtheoretical model of changes, cognitive-behavioral therapy, extended preventive counseling.
Other Name: Motivational Interviewing

Diagnostic Test: Lipid analysis
Assessment of total cholesterol, low density lipoproteins, high density lipoproteins, triglycerides, alanine aminotransferase.

Other: Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet)
All patients will be prescribed ezetimibe and statins (atorvastatin / rosuvastatin) at the maximum dosage. If somebody has an intolerance to atorvastatin, the drug will be replaced with rosuvastatin and vice versa. In case of intolerance to all drugs from the statin group, the patient will be prescribed ezetimibe with a PCSK9 inhibitor (alirocumab / evolocumab). After receiving the results of the lipid spectrum, ALT, if necessary, the lipid-lowering therapy may be corrected.

Other: Visit 1

Visit 1: initially (on enrollment) - informed consents signing; lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid-lowering therapy and lifestyle; filling all questionnaires. After this visit patients are randomized to groups with or without genetic testing and then randomized to groups with or without motivational counseling.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform, a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days.


Other: Visit 2

Visit 2 (in 2-3 months): lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid lowering-therapy and lifestyle; filling all questionnaires. Patients from the group with genetic testing will get the result of this genetic testing. Patients from the group with motivational counseling will get two consultations with a psychologist (motivational counseling on lifestyle modification) during Visit 2 and in one month after Visit 2.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days


Other: Visit 3

Visit 3 (in 3 months after Visit 2): lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid-lowering therapy and lifestyle; filling all questionnaires.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days.


Other: Visit 4

Visit 4 (in 12 months after Visit 3): lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid-lowering therapy and lifestyle; filling all questionnaires.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days.
Experimental: Group 2 - with genetic testing; subgroup without motivational counseling
Group 2 - genetic testing has been performed; subgroup without motivational counseling.
 Genetic: Genetic Testing
DNA is extracted using the QIAamp® DNA Blood Mini Kit (Qiagen, Germany). The DNA concentration is measured on a Qubit 4.0 fluorometer (Thermo Fisher Scientific, USA (TFS)). NGS is performed on Nextseq 550 (Illumina, San Diego, CA, USA). The library preparation is performed using the SeqCap EZ Prime Choice Library kit (Roche, Basel, Switzerland). The Roche panel is used, consisting of 244 (CDS + 25 bp padding) genes including LDLR, APOB, and PCSK9. Reads are aligned to the reference genome (GRCh37). Sequencing analysis resultes in fastq files. Data processing is performed with BWA, Picard, bcftools, GATK3 and generally followed the GATK best practices for variant calling. For clinical interpretation, genetic variants with frequencies in the gnomAD database <0.5% are selected. The pathogenicity of variants is assessed according to the ACMG / AMP2015 guidelines. The identified SNPs are validated by Sanger sequencing (3500 DNA Analyzer, TFS).

Diagnostic Test: Lipid analysis
Assessment of total cholesterol, low density lipoproteins, high density lipoproteins, triglycerides, alanine aminotransferase.

Other: Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet)
All patients will be prescribed ezetimibe and statins (atorvastatin / rosuvastatin) at the maximum dosage. If somebody has an intolerance to atorvastatin, the drug will be replaced with rosuvastatin and vice versa. In case of intolerance to all drugs from the statin group, the patient will be prescribed ezetimibe with a PCSK9 inhibitor (alirocumab / evolocumab). After receiving the results of the lipid spectrum, ALT, if necessary, the lipid-lowering therapy may be corrected.

Other: Visit 1

Visit 1: initially (on enrollment) - informed consents signing; lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid-lowering therapy and lifestyle; filling all questionnaires. After this visit patients are randomized to groups with or without genetic testing and then randomized to groups with or without motivational counseling.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform, a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days.


Other: Visit 2

Visit 2 (in 2-3 months): lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid lowering-therapy and lifestyle; filling all questionnaires. Patients from the group with genetic testing will get the result of this genetic testing. Patients from the group with motivational counseling will get two consultations with a psychologist (motivational counseling on lifestyle modification) during Visit 2 and in one month after Visit 2.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days


Other: Visit 3

Visit 3 (in 3 months after Visit 2): lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid-lowering therapy and lifestyle; filling all questionnaires.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days.


Other: Visit 4

Visit 4 (in 12 months after Visit 3): lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid-lowering therapy and lifestyle; filling all questionnaires.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days.
Experimental: Group 2 - with genetic testing; subgroup with motivational counseling
Group 2 - genetic testing has been performed; subgroup with motivational counseling.
 Genetic: Genetic Testing
DNA is extracted using the QIAamp® DNA Blood Mini Kit (Qiagen, Germany). The DNA concentration is measured on a Qubit 4.0 fluorometer (Thermo Fisher Scientific, USA (TFS)). NGS is performed on Nextseq 550 (Illumina, San Diego, CA, USA). The library preparation is performed using the SeqCap EZ Prime Choice Library kit (Roche, Basel, Switzerland). The Roche panel is used, consisting of 244 (CDS + 25 bp padding) genes including LDLR, APOB, and PCSK9. Reads are aligned to the reference genome (GRCh37). Sequencing analysis resultes in fastq files. Data processing is performed with BWA, Picard, bcftools, GATK3 and generally followed the GATK best practices for variant calling. For clinical interpretation, genetic variants with frequencies in the gnomAD database <0.5% are selected. The pathogenicity of variants is assessed according to the ACMG / AMP2015 guidelines. The identified SNPs are validated by Sanger sequencing (3500 DNA Analyzer, TFS).

Behavioral: Motivational Counseling

Motivational counseling will be carried out during Visit 2 and in one month after Visit 2 by certified psychologist with taking into account the results of the psychodiagnostic survey conducted at the first and second visits.

The goals of motivational counseling:

  1. Increasing motivation for a healthy lifestyle;
  2. Increasing adherence to treatment;
  3. Increased motivation to invite relatives for cascade screening. Motivational counseling will be carried out using methods of motivational interviewing, transtheoretical model of changes, cognitive-behavioral therapy, extended preventive counseling.
Other Name: Motivational Interviewing

Diagnostic Test: Lipid analysis
Assessment of total cholesterol, low density lipoproteins, high density lipoproteins, triglycerides, alanine aminotransferase.

Other: Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet)
All patients will be prescribed ezetimibe and statins (atorvastatin / rosuvastatin) at the maximum dosage. If somebody has an intolerance to atorvastatin, the drug will be replaced with rosuvastatin and vice versa. In case of intolerance to all drugs from the statin group, the patient will be prescribed ezetimibe with a PCSK9 inhibitor (alirocumab / evolocumab). After receiving the results of the lipid spectrum, ALT, if necessary, the lipid-lowering therapy may be corrected.

Other: Visit 1

Visit 1: initially (on enrollment) - informed consents signing; lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid-lowering therapy and lifestyle; filling all questionnaires. After this visit patients are randomized to groups with or without genetic testing and then randomized to groups with or without motivational counseling.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform, a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days.


Other: Visit 2

Visit 2 (in 2-3 months): lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid lowering-therapy and lifestyle; filling all questionnaires. Patients from the group with genetic testing will get the result of this genetic testing. Patients from the group with motivational counseling will get two consultations with a psychologist (motivational counseling on lifestyle modification) during Visit 2 and in one month after Visit 2.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days


Other: Visit 3

Visit 3 (in 3 months after Visit 2): lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid-lowering therapy and lifestyle; filling all questionnaires.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days.


Other: Visit 4

Visit 4 (in 12 months after Visit 3): lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid-lowering therapy and lifestyle; filling all questionnaires.

Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days.


Outcome Measures
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Primary Outcome Measures :
  1. Change in the proportion of people who have reached the target level of LDL-Cholesterol [ Time Frame: 3 months ]
    Change in the proportion of people who have reached the target level of LDL-Cholesterol (target values of LDL-C according to the ESC Dislipidaemia Guidelines 2019)

  2. Change in the number of relatives who underwent cascade screening [ Time Frame: 3 months ]
    Change in the number of relatives who underwent cascade screening (% of relatives out of all available relatives. Available relatives are those who are alive and live in the region of where the study is conducted (Moscow and Moscow region)

  3. Change in the proportion of people adhering to drug therapy [ Time Frame: 3 months ]
    Change in the proportion of people adhering to drug therapy according to the questionnaire MARS-5

  4. Change in the proportion of people adhering to the recommended physical activity [ Time Frame: 3 months ]
    Change in the proportion of people adhering to the recommended physical activity (according to the Global Physical Activity Questionnaire (GPAQ))

  5. Change in the proportion of individuals adhering to the recommended dietary recommendations [ Time Frame: 3 months ]
    Change in the proportion of individuals adhering to the recommended dietary recommendations (according to 24-hour Dietary Recall and Food Frequency Questionnaires)


Secondary Outcome Measures :
  1. Change in the proportion of people who have reached the target level of LDL-Cholesterol [ Time Frame: 15 months ]
    Change in the proportion of people who have reached the target level of LDL-Cholesterol (target values of LDL-C according to the ESC Dislipidaemia Guidelines 2019)

  2. Change in the number of relatives who underwent cascade screening [ Time Frame: 15 months ]
    Change in the number of relatives who underwent cascade screening (% of relatives out of all available relatives. Available relatives are those who are alive and live in the region of where the study is conducted (Moscow and Moscow region)

  3. Change in the proportion of people adhering to drug therapy [ Time Frame: 15 months ]
    Change in the proportion of people adhering to drug therapy according to the questionnaire MARS-5

  4. Change in the proportion of people adhering to the recommended physical activity [ Time Frame: 15 months ]
    Change in the proportion of people adhering to the recommended physical activity (according to the Global Physical Activity Questionnaire (GPAQ))

  5. Change in the proportion of individuals adhering to the recommended dietary recommendations [ Time Frame: 15 months ]
    Change in the proportion of individuals adhering to the recommended dietary recommendations (according to 24-hour Dietary Recall and Food Frequency Questionnaires)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04656028


Contacts
Layout table for location contacts
Contact: Alexandra Ershova, MD, PhD +79165598536 alersh@mail.ru
Contact: Alexey Meshkov, MD, PhD +79015121271 meshkov@lipidclinic.ru

Locations
Layout table for location information
Russian Federation
National Medical Research Centre for Therapy and Preventive Medicine of the Ministry of Health of Russia Recruiting
Moscow, Russian Federation, 101000
Contact: Alexandra Ershova, MD, PhD    +79165598536    alersh@mail.ru   
Contact: Alexey Meshkov, MD, PhD    +79015121271    meshkov@lipidclinic.ru   
Principal Investigator: Alexey Meshkov, MD, PhD         
Sub-Investigator: Alexandra Ershova, MD, PhD         
Sponsors and Collaborators
National Medical Research Center for Therapy and Preventive Medicine
Moscow State University of Medicine and Dentistry
Investigators
Layout table for investigator information
Principal Investigator: Alexey Meshkov, MD, PhD National Medical Research Centre for Therapy and Preventive Medicine, Ministry of Health of Russia
Study Director: Alexandra Ershova, MD, PhD National Medical Research Centre for Therapy and Preventive Medicine, Ministry of Health of Russia
More Information
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Layout table for additonal information
Responsible Party: National Medical Research Center for Therapy and Preventive Medicine
ClinicalTrials.gov Identifier: NCT04656028    
Other Study ID Numbers: 08-03/19
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: March 29, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Medical Research Center for Therapy and Preventive Medicine:
Familial Hypercholesterolemia
FH
genetic testing
motivational counseling
motivational interviewing
cascade screening
adherence
compliance
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
Therapeutic Adherence
Therapeutic Adherence and Compliance
Patient Adherence
Familial Hypercholesterolemia - Heterozygous
psychological counseling
Adherence, Patient
Adherence, Medication
Treatment Adherence
Medication Adherence
Treatment Adherence and Compliance
Patient Compliance
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthrogryposis
Hyperlipoproteinemia Type II
Hyperlipoproteinemia Type III
Hypercholesterolemia
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
 Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities