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

Recruiting

Conditions

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

Observational

Enrollment (Estimated)

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 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

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
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

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

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

Russian Cardiology Research and Production Center

Collaborators

Research Centre for Medical Genetics, Russian Federation

Investigators

  • 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)

November 20, 2025

Primary Completion (Estimated)

December 1, 2045

Study Completion (Estimated)

December 1, 2045

Study Registration Dates

First Submitted

February 28, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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