Russian Extreme Hypertriglyceridemia Registry (REGGI)

March 27, 2026 updated by: Marat Vladislavovich Ezhov (MV Ezhov, MD, PhD, DMSc), Russian Cardiology Research and Production Center

Russian Extreme Hypertriglyceridemia Registry (REGGI)

The REGGI registry is a prospective, multicenter observational registry in Russia designed to collect data on patients with extreme hypertriglyceridemia (triglyceride levels ≥10 mmol/L). The registry aims to describe the clinical, demographic, and molecular-genetic characteristics of patients, as well as current diagnostic approaches and treatment patterns in real-world practice. The collected data may inform future research and support improvements in patient care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Hypertriglyceridemia (HTG) is associated with an increased risk of atherosclerotic cardiovascular disease, acute pancreatitis, and all-cause mortality. The risk increases with higher triglyceride levels and is most significant in extreme HTG (triglyceride concentration ≥10 mmol/L). Epidemiological studies in the Russian Federation report a prevalence of extreme HTG of approximately 0.1-0.2% (146,000-292,000 individuals). Extreme HTG can have monogenic or polygenic (multifactorial) origins, which influences the clinical course of the disease.

Written informed consent is obtained from the patient or their legal guardian prior to inclusion.

Data sources include routine diagnostic findings and medical records. Participating sites monitor patients' clinical status as part of routine medical care. There are no interventions in this registry: medications are not changed, no invasive procedures are performed, and no study-specific interventions or procedures associated with additional risk are performed. Only clinical course, laboratory results, lipid profile, and therapeutic measures are documented, including any genetic testing if available.

Patients are followed annually or more frequently if clinically indicated. There is no minimum or maximum age for inclusion, and follow-up duration is not predefined and depends on clinical practice. Participation is voluntary, and patients may withdraw at any time without affecting their medical care. Data are pseudonymized and can be decrypted using a separately maintained key list; data can be deleted upon patient request.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Russia
      • Astrakhan, Russia
        • Recruiting
        • Astrakhan State Medical University
        • Contact:
      • Chelyabinsk, Russia
        • Recruiting
        • Chelyabinsk State Medical Academy
        • Contact:
        • Contact:
      • Kaluga, Russia
      • Kazan', Russia
      • Moscow, Russia
        • Recruiting
        • National Medical Research Center of Cardiology Named after Academician E.I. Chazov
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marat Ezhov, MD, PhD
        • Sub-Investigator:
          • Uliana Chubykina, MD, PhD
      • Moscow, Russia
        • Recruiting
        • Research Centre for Medical Genetics
        • Contact:
        • Sub-Investigator:
          • Petr Vasiluev, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with extreme hypertriglyceridemia (triglyceride levels ≥10 mmol/L) who are receiving care at participating lipid centers in the Russian Federation. Both pediatric and adult patients are eligible. Data collection includes routine clinical assessments, laboratory tests, lipid profiles, and genetic analyses if available. Participation is voluntary, and patients may withdraw at any time without affecting their medical care.

Description

Inclusion Criteria:

  • Patients with extreme hypertriglyceridemia (triglyceride levels ≥10 mmol/L), confirmed by at least two independent measurements.
  • Written informed consent from the patient or legal guardian.
  • No age restrictions.

Exclusion Criteria:

  • Patients whose extreme hypertriglyceridemia is caused by alcohol abuse, uncontrolled diabetes, or other medical conditions, unless extreme hypertriglyceridemia is confirmed after controlling the underlying condition.
  • Lack of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Extreme Hypertriglyceridemia
Patients with triglyceride levels ≥10 mmol/L, confirmed by at least two independent measurements, under the care of participating lipid centers in the Russian Federation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality (all-cause and cardiovascular)
Time Frame: Baseline and through study completion, an average of 20 years
Collection of all-cause and cardiovascular mortality data from patient records and routine follow-up visits.
Baseline and through study completion, an average of 20 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major Cardiovascular Events (MACE)
Time Frame: Baseline and through study completion, an average of 20 years
Number of participants experiencing major adverse cardiovascular events including myocardial infarction, stroke, percutaneous coronary intervention, coronary artery bypass grafting, carotid or lower extremity revascularization, or aortic valve replacement documented in medical records.
Baseline and through study completion, an average of 20 years
Pancreatitis Recurrences
Time Frame: Baseline and through study completion, an average of 20 years
Number of participants with recurrent episodes of acute pancreatitis documented in medical records during routine follow-up visits.
Baseline and through study completion, an average of 20 years
Pancreatic Necrosis
Time Frame: Baseline and through study completion, an average of 20 years
Number of participants with pancreatic necrosis confirmed by imaging studies and documented in medical records.
Baseline and through study completion, an average of 20 years
Low-Density Lipoprotein Cholesterol (LDL-C)
Time Frame: Baseline and through study completion, an average of 20 years
Measurement of LDL-C levels obtained from routine laboratory testing. LDL-C concentrations are reported in mmol/L.
Baseline and through study completion, an average of 20 years
Triglyceride
Time Frame: Baseline and through study completion, an average of 20 years
Measurement of triglyceride levels obtained from routine laboratory testing. Triglyceride concentrations are reported in mmol/L.
Baseline and through study completion, an average of 20 years
Total Cholesterol
Time Frame: Baseline and through study completion, an average of 20 years
Measurement of total cholesterol levels obtained from routine laboratory testing. Total cholesterol concentrations are reported in mmol/L.
Baseline and through study completion, an average of 20 years
High-Density Lipoprotein Cholesterol (HDL-C)
Time Frame: Baseline and through study completion, an average of 20 years
Measurement of HDL-C levels obtained from routine laboratory testing. HDL-C concentrations are reported in mmol/L.
Baseline and through study completion, an average of 20 years
Genetic Characterization of Extreme Hypertriglyceridemia
Time Frame: Baseline (at the time of genetic testing) and during follow-up if additional genetic data become available, through study completion (an average of 20 years).
Assessment of genetic variants associated with extreme hypertriglyceridemia in a subset of participants where genetic testing is available. Genetic analysis includes identification and classification of variants in genes involved in triglyceride metabolism (e.g., LPL, APOC2, APOA5, GPIHBP1, LMF1) according to established criteria (e.g., ACMG). The proportion of participants with pathogenic or likely pathogenic variants, as well as variants of uncertain significance, will be reported.
Baseline (at the time of genetic testing) and during follow-up if additional genetic data become available, through study completion (an average of 20 years).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Russian Cardiology Research and Production Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Research Centre for Medical Genetics, Russian Federation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marat Ezhov, MD, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2045

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2045

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REGGI-HTG-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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