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.
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
500
Astrakhan State Medical University
Astrakhan, Russia
RECRUITINGChelyabinsk State Medical Academy
Chelyabinsk, Russia
RECRUITINGKaluga City Clinical Hospital No. 5
Kaluga, Russia
Mortality (all-cause and cardiovascular)
Collection of all-cause and cardiovascular mortality data from patient records and routine follow-up visits.
Time frame: Baseline and through study completion, an average of 20 years
Major Cardiovascular Events (MACE)
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.
Time frame: Baseline and through study completion, an average of 20 years
Pancreatitis Recurrences
Number of participants with recurrent episodes of acute pancreatitis documented in medical records during routine follow-up visits.
Time frame: Baseline and through study completion, an average of 20 years
Pancreatic Necrosis
Number of participants with pancreatic necrosis confirmed by imaging studies and documented in medical records.
Time frame: Baseline and through study completion, an average of 20 years
Low-Density Lipoprotein Cholesterol (LDL-C)
Measurement of LDL-C levels obtained from routine laboratory testing. LDL-C concentrations are reported in mmol/L.
Time frame: Baseline and through study completion, an average of 20 years
Triglyceride
Measurement of triglyceride levels obtained from routine laboratory testing. Triglyceride concentrations are reported in mmol/L.
Time frame: Baseline and through study completion, an average of 20 years
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State Medical University
Kazan', Russia
RECRUITINGNational Medical Research Center of Cardiology Named after Academician E.I. Chazov
Moscow, Russia
RECRUITINGResearch Centre for Medical Genetics
Moscow, Russia
RECRUITINGTotal Cholesterol
Measurement of total cholesterol levels obtained from routine laboratory testing. Total cholesterol concentrations are reported in mmol/L.
Time frame: Baseline and through study completion, an average of 20 years
High-Density Lipoprotein Cholesterol (HDL-C)
Measurement of HDL-C levels obtained from routine laboratory testing. HDL-C concentrations are reported in mmol/L.
Time frame: Baseline and through study completion, an average of 20 years
Genetic Characterization of Extreme Hypertriglyceridemia
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.
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).