NCT06683001

Brief Summary

A prospective-retrospective observational registry of patients diagnosed with chronic heart failure in the regions of the Russian Federation. The study is non-interventional and does not involve any interventions in clinical practice, the choice of treatment methods (including the type of medical device used and the method of surgical intervention) and examination. A control observation group is not intended.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Oct 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

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 Progress49%
Oct 2024Dec 2027

Study Start

First participant enrolled

October 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3.2 years

First QC Date

November 7, 2024

Last Update Submit

April 8, 2026

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (8)

  • Age of subjects with different phenotypes and stages of CHF

    Every 12 months, up to 3 years

  • Female to male sex ratio of subjects with different phenotypes and stages of CHF

    Every 12 months, up to 3 years

  • Clinical status of subjects with different phenotypes and stages of CHF

    Every 12 months, up to 3 years

  • Proportion of employable and working subjects with different phenotypes and stages of CHF

    Every 12 months, up to 3 years

  • The proportion of subjects with different algorithms for diagnosing CHF and the proportion of subjects with a verified diagnosis of CHF (established according to the recommended algorithm for diagnosing CHF)

    Every 12 months, up to 3 years

  • The proportion of subjects taking drugs of each class and all four classes of the recommended four-component therapy regimen (in the overall choice and in different phenotypes of CHF; working/non-working age; working/non-working)

    Every 12 months, up to 3 years

  • Number and proportion of subjects with wearable devices when using an online tool for identifying subjects with CHF with indications for high-tech medical care

    Every 12 months, up to 3 years

  • Number and proportion of subjects when using an online tool for identifying subjects with CHF with indications for high-tech medical care

    Every 12 months, up to 3 years

Secondary Outcomes (14)

  • Proportions of subjects with an increase in EF ≥10% and a decrease in the functional class of CHF by 1 point

    Every 12 months, up to 3 years

  • The proportion of subjects hospitalized for decompensated CHF in the departments of therapeutic and cardiology profiles *

    Every 12 months, up to 3 years

  • Proportion of subjects with newly diagnosed type 2 diabetes*

    Every 12 months

  • Proportion of subjects with deterioration of renal function*

    Every 12 months, up to 3 years

  • Proportion of subjects with newly diagnosed malignant neoplasm*

    Every 12 months, up to 3 years

  • +9 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

At least 3% of CHF subjects in the target regions of Russia will be included in that trial by performing thier medical records analysis

You may qualify if:

  • Any stage and/or any class of CHF

You may not qualify if:

  • Subjects whose source records cant be obtained for the analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Organization

Moscow, Russia

RECRUITING

Study Officials

  • Sergey A Boytsov, Prof.

    E.I.Chazov Cardiology Center

    STUDY CHAIR

  • Zoya N Blankova, MD, PhD

    E.I.Chazov Cardiology Center

    STUDY DIRECTOR

  • Fail' T Ageev, Prof.

    E.I.Chazov Cardiology Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga N Svirida, MD, PhD

CONTACT

+74954146552ONSvirida@Cardio.ru

Vadim Yu Kuznetsov, PhD

CONTACT

+74954146249vykuznetsov@cardio.ru

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2024

First Posted

November 12, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

RU(1)