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Chronic Non-communicable DiseasesSOFITNCT06803862

RegiStry Of the multiFaceted medIcal cenTer

An observational study of Chronic Non-communicable Diseases and Cardiovascular Diseases, run by National Medical Research Center for Therapy and Preventive Medicine at 2 sites in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is a prospective medical registry (the SOFIT Registry) that enrolls all patients hospitalized in various departments of the Tula Regional Clinical Hospital in 2021. The primary objective of the study is to analyze demographic, clinical and anamnestic characteristics of patients, history of COVID-19, the… Read more about this study

Who is it for?
Ages 18 years and older
How many people
21,783 participants
Where
2 sitesRussia
Study dates
1 Jan 2021to 31 Dec 2026
How long will I take part?
5 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients admitted to the Tula Regional Clinical Hospital from 01.01.2021 to 31.12.2021 who meet inclusion criteria and don't have exclusion criteria will be included in this study.

Who may be able to join

  • Patients hospitalized to the Tula Regional Clinical Hospital from 01.01.2021 to 31.12.2021.
  • Age 18 years and older.
  • Permanent residency in Tula city and Tula region.

Who cannot join

  • 1. Permanent residency outside of Tula city and Tula region.

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

  • National Research Center for Preventive Medicine of the Ministry of Health

    Moscow, 101990

  • State Healthcare Institution of the Tula Region Tula Regional Clinical Hospital

    Tula, 300053

Other trials in Russia

About this study

This study is a prospective medical registry (the SOFIT Registry) that enrolls all patients hospitalized in various departments of the Tula Regional Clinical Hospital in 2021.

The primary objective of the study is to analyze demographic, clinical and anamnestic characteristics of patients, history of COVID-19, the structure of multimorbidity, the quality of diagnostics and treatment, as well as short-term and long-term outcomes. As a part of this project a five-year follow-up is planned. The information will be obtained from Medical Information System resource of the hospital and regional and federal electronic databases.

Read the detailed description

Nowadays in the Russian Federation chronic non-communicable diseases are one of the most common causes of hospitalization and also a concomitant pathology in the majority of patients undergoing hospital treatment in departments of various profiles. The creation of a prospective medical registry is an informative method for a comprehensive assessment of the characteristics of patients, including demographic, clinical and anamnestic data, the structure of multimorbidity, the quality of diagnostics and treatment as well as an assessment of short-term and long-term outcomes.

The aim of this project is to create a prospective registry of a multifaceted medical center (SOFIT), including all patients hospitalized in various departments of the hospital.

Patients admitted to the Tula Regional Clinical Hospital from 01.01.2021 to 31.12.2021 were retrospectively enrolled into this study. The information from electronic medical records was obtained using the Medical Information System resource of the hospital.

At the first stage, it is planned to analyze the age and gender characteristics of patients, the proportion of cases of cardiovascular and chronic non-cardiac diseases and their combinations, the frequency of a history of COVID-19, laboratory and instrumental data, cardiovascular pharmacotherapy prescribed in the hospital and hospital mortality. The obtained data will be compared in the cardiologic, therapeutic and other departments.

At the second stage, the prospective follow-up will be carried out up to 5 years after the reference hospitalization. It will involve the evaluation of long-term outcomes, such as all-cause mortality, cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal cerebral stroke, hospitalizations and surgical interventions for cardiovascular diseases), cases of COVID-19 based on patient's medical records. The information about cases of death (date and cause of death, place of death registration), cardiovascular events during follow-up will be obtained from the regional database of death cases in population of the Tula region and from other regional electronic databases. The information about cases of COVID-19 will be obtained from the Russian Federal Registry of COVID-19.

Keywords
hospital registry, multifaceted medical center, cardiovascular diseases, multimorbidity, chronic non-communicable diseases
Medical subject headings
Noncommunicable Diseases, Cardiovascular Diseases, COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Measured: 5 years after inclusion

  2. Time to all-cause mortality, cardiovascular mortality, nonfatal myocardial infarction, nonfatal cerebral stroke, coronary/carotid revascularization

    Measured: from discharge up to 5 years after reference hospitalization

Secondary outcomes (6)

  1. Time to composite endpoint (nonfatal myocardial infarction or nonfatal cerebral stroke or coronary/carotid revascularization)

    Measured: from discharge up to 5 years after reference hospitalization

  2. Proportion of patients with nonfatal myocardial infarction

    Measured: from discharge up to 5 years after reference hospitalization

  3. Proportion of patients with nonfatal cerebral stroke

    Measured: from discharge up to 5 years after reference hospitalization

  4. Proportion of patients with cases of COVID-19 during follow-up

    Measured: from discharge up to 5 years after reference hospitalization

  5. Hospitalization due to cardiovascular disease, proportion of patients with hospitalization due to cardiovascular disease

    Measured: from discharge up to 5 years after reference hospitalization

  6. Hospitalization due to COVID-19, proportion of patients with hospitalization due to COVID-19

    Measured: from discharge up to 5 years after reference hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2025
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
21,783 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06803862
Sponsor's protocol ID
01-10/22
Acronym
SOFIT
Status last verified
May 2026
First submitted
27 Jan 2025
Last updated
20 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ignatieva VI, Kontsevaya AV, Lukyanov MM, et al. Cost-effectiveness analysis of increasing drug therapy coverage for patients with coronary artery disease in combination with atrial fibrillation and heart failure. Cardiovascular Therapy and Prevention. 2024;23(4):3950. (In Russ.) https://doi.org/10.15829/1728-8800-2024-3950

  • Loukianov MM, Gomova TA, Savishceva AA, et al. RegiStry Of the multiFaceted medIcal cenTer (SOFIT): the main tasks, development, and the first results. Russian Journal of Preventive Medicine. 2023;26(6):46 54. (In Russ.) https://doi.org/10.17116/profmed20232606146

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Non-communicable Diseases and Cardiovascular Diseases, run by National Medical Research Center for Therapy and Preventive Medicine at 2 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 1 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: 5 years after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06803862, which also lists 2 linked publications.

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 20 May 2026.

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