NCT07508930

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
237mo left

Started Nov 2025

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Nov 2025Dec 2045

Study Start

First participant enrolled

November 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
19.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2045

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2045

Last Updated

April 2, 2026

Status Verified

February 1, 2026

Enrollment Period

20 years

First QC Date

February 28, 2026

Last Update Submit

March 27, 2026

Conditions

Hypertriglyceridemia

Keywords

Acute Pancreatitiscardiovascular diseases

Outcome Measures

Primary Outcomes (1)

  • Mortality (all-cause and cardiovascular)

    Collection of all-cause and cardiovascular mortality data from patient records and routine follow-up visits.

    Baseline and through study completion, an average of 20 years

Secondary Outcomes (8)

  • Major Cardiovascular Events (MACE)

    Baseline and through study completion, an average of 20 years

  • Pancreatitis Recurrences

    Baseline and through study completion, an average of 20 years

  • Pancreatic Necrosis

    Baseline and through study completion, an average of 20 years

  • Low-Density Lipoprotein Cholesterol (LDL-C)

    Baseline and through study completion, an average of 20 years

  • Triglyceride

    Baseline and through study completion, an average of 20 years

  • +3 more secondary outcomes

Study Arms (1)

Extreme Hypertriglyceridemia

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Astrakhan State Medical University

Astrakhan, Russia

RECRUITING

Chelyabinsk State Medical Academy

Chelyabinsk, Russia

RECRUITING

Kaluga City Clinical Hospital No. 5

Kaluga, Russia

RECRUITING

State Medical University

Kazan', Russia

RECRUITING

National Medical Research Center of Cardiology Named after Academician E.I. Chazov

Moscow, Russia

RECRUITING

Research Centre for Medical Genetics

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

HypertriglyceridemiaPancreatitisCardiovascular Diseases

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPancreatic DiseasesDigestive System Diseases

Study Officials

  • Marat Ezhov

    MD, PhD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marat Ezhov, MD, PhD

CONTACT

+7 495 414-6067Marat_Ezhov@mail.ru

Uliana Chubykina, MD, PhD

CONTACT

+7 495 414-6067uliankachubykina@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2026

First Posted

April 2, 2026

Study Start

November 20, 2025

Primary Completion (Estimated)

December 1, 2045

Study Completion (Estimated)

December 1, 2045

Last Updated

April 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

RU(6)