Russian Extreme Hypertriglyceridemia Registry
ConditionHypertriglyceridemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorRussian Cardiology Research and Production Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Extreme Hypertriglyceridemia
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Russian Cardiology Research and Production Center
Lead sponsor
Research Centre for Medical Genetics, Russian Federation
Collaborator
Source ClinicalTrials.gov