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NCT Number: NCT07508930

Russian Extreme Hypertriglyceridemia Registry

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.

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Key information

Conditions

Hypertriglyceridemia Cardiovascular Diseases Digestive System Diseases Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatitis

Sex eligibility

All sexes

Study type

Observational

Primary location

Astrakhan State Medical University, Astrakhan, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marat Ezhov, MD, PhD

CONTACT

[email protected]

+7 495 414-6067

Uliana Chubykina, MD, PhD

CONTACT

[email protected]

+7 495 414-6067

Sponsors and collaborators

Lead sponsor

Russian Cardiology Research and Production Center

Other

Collaborators

  • Research Centre for Medical Genetics, Russian Federation

Registry information

Official study title

Russian Extreme Hypertriglyceridemia Registry (REGGI)

Acronym: REGGI

Important dates

Study start
2025
Primary completion
2045
Study completion
2045
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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