HypertriglyceridemiaREGGINCT07508930
Russian Extreme Hypertriglyceridemia Registry
An observational study of Hypertriglyceridemia, run by Russian Cardiology Research and Production Center at 6 sites in Russia.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertriglyceridemia
- How many people
- 500 participants
- Where
- 6 sitesRussia
- Study dates
- 20 Nov 2025to Dec 2045
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Russia6 sites, 6 recruiting
- Recruiting
Astrakhan State Medical University
Astrakhan
Natalia Androsyuk, MD, +7 495 414-6067, vasilisa201012@yandex.ru
- Recruiting
Chelyabinsk State Medical Academy
Chelyabinsk
Igor Shaposhnik, MD, DMSc, +7 495 414-6067, shaposhnik@yandex.ru
Vadim Genkel, MD, PhD, henkel-07@mail.ru
- Recruiting
Kaluga City Clinical Hospital No. 5
Kaluga
Andrey Baglikov, MD, PhD, +7 495 414-6067, baglikov_andrey@mail.ru
Nikolay Novitskiy, MD, PhD, novitskiynic@gmail.com
- Recruiting
State Medical University
Kazan'
Dinara Sadykova, MD, PhD, +7 495 414-6067, sadykovadi@mail.ru
Chulpan Khaliullina, MD, chulpandanilevna@yandex.ru
- Recruiting
National Medical Research Center of Cardiology Named after Academician E.I. Chazov
Moscow
Marat Ezhov, MD, PhD, +7 495 414-6067, Marat_Ezhov@mail.ru
Uliana Chubykina, MD, PhD, uliankachubykina@gmail.com
- Recruiting
Research Centre for Medical Genetics
Moscow
Petr Vasiluev, MD, PhD, +7 495 414-6067, vasiluev@med-gen.ru
Petr Vasiluev, MD, PhD
About this study
Official title: Russian Extreme Hypertriglyceridemia Registry (REGGI)
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.
Read the 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.
- Conditions
- Hypertriglyceridemia
- Keywords
- Acute Pancreatitis, cardiovascular diseases
- Medical subject headings
- Hypertriglyceridemia, Pancreatitis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality (all-cause and cardiovascular)
Collection of all-cause and cardiovascular mortality data from patient records and routine follow-up visits.
Measured: Baseline and through study completion, an average of 20 years
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start20 Nov 2025
- Primary completionDec 2045 (estimated)
- Study completionDec 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Russian Cardiology Research and Production Center
- Sponsor type
- University, hospital or other
- Collaborators
- Research Centre for Medical Genetics, Russian Federation
- Responsible party
- Principal investigator, Marat Vladislavovich Ezhov (MV Ezhov, MD, PhD, DMSc), Russian Cardiology Research and Production Center
- Investigators
- Marat Ezhov, Principal investigator, MD, PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508930
- Sponsor's protocol ID
- REGGI-HTG-2025
- Acronym
- REGGI
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Russian Extreme Hypertriglyceridemia Registry (REGGI)
- ClinicalTrials.gov ID
- NCT07508930
- Acronym / sponsor ID
- REGGI / REGGI-HTG-2025
- Conditions
- Hypertriglyceridemia
- Keywords
- Acute Pancreatitis, cardiovascular diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Russian Cardiology Research and Production CenterUniversity, hospital or other
- Collaborators
- Research Centre for Medical Genetics, Russian Federation
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Dec 2045 (estimated)
- Study completion
- Dec 2045 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality (all-cause and cardiovascular)
Time frame: 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.
8 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Hypertriglyceridemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
Active, not recruitingPhase 2
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
Diabetes, Lipodystrophy
RecruitingPhase 1
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Hypercholesterolemia, Hypertriglyceridemia
Not yet recruitingPhase 2
A Phase II Study of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With ASCVD.
sHTG, HTG With ASCVD (Diagnosed or at Increased Risk)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marat Ezhov principal investigator
MD, PhD
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertriglyceridemia, run by Russian Cardiology Research and Production Center at 6 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marat Ezhov, MD, PhD (+7 495 414-6067, Marat_Ezhov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (all-cause and cardiovascular) (time frame: Baseline and through study completion, an average of 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.