An observational study in Hypertriglyceridemia, sponsored by Russian Cardiology Research and Production Center. Recruiting at 6 sites in Russia. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Russian Cardiology Research and Production Center · Observational
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.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's planned enrollment of 500 is above the median of 150 across 21 observational studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →Russian Cardiology Research and Production Center is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Total 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).
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Dec 2045, 241 months after the start.
How these figures are worked out, and which studies are left out of them.
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Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Russian Cardiology Research and Production Center