Hypertriglyceridemia
Conditions
Keywords
Acute Pancreatitis, cardiovascular diseases
Brief summary
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.
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.
Interventions
None listed
Sponsors
Russian Cardiology Research and Production Center
Research Centre for Medical Genetics, Russian Federation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality (all-cause and cardiovascular) | 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
| Measure | Time frame | Description |
|---|---|---|
| Major Cardiovascular Events (MACE) | 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. |
| Pancreatitis Recurrences | 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. |
| Pancreatic Necrosis | 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. |
| Low-Density Lipoprotein Cholesterol (LDL-C) | 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. |
| Triglyceride | 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. |
| Total Cholesterol | 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. |
| High-Density Lipoprotein Cholesterol (HDL-C) | 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. |
| Genetic Characterization of Extreme Hypertriglyceridemia | 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. |
Countries
Russia
Contacts
CONTACTMarat Ezhov, MD, PhD
CONTACTUliana Chubykina, MD, PhD
PRINCIPAL_INVESTIGATORMarat Ezhov
MD, PhD
Outcome results
None listed