Russian Extreme Hypertriglyceridemia Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hypertriglyceridemia. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Russian Extreme Hypertriglyceridemia Registry (REGGI)
Overview
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.
Primary outcome measures
- Mortality (all-cause and cardiovascular) [Time frame: Baseline and through study completion, an average of 20 years]
Secondary outcome measures (8)
- Major Cardiovascular Events (MACE) [Time frame: Baseline and through study completion, an average of 20 years]
- Pancreatitis Recurrences [Time frame: Baseline and through study completion, an average of 20 years]
- Pancreatic Necrosis [Time frame: 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]
- Triglyceride [Time frame: Baseline and through study completion, an average of 20 years]
- Total Cholesterol [Time frame: 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]
- 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).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 6 centers
- Astrakhan State Medical University — Astrakhan
- Chelyabinsk State Medical Academy — Chelyabinsk
- Kaluga City Clinical Hospital No. 5 — Kaluga
- State Medical University — Kazan'
- National Medical Research Center of Cardiology Named after Academician E.I. Chazov — Moscow
- Research Centre for Medical Genetics — Moscow
Identifiers
NCT: NCT07508930 · REGGI-HTG-2025