National Heart Failure Registry

CHaracterization Of the STate of the System of Care for Patients With Chronic Heart Failure in the Regions of the Russian Federation: Identification, Diagnostics, Treatment, Observation

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Heart Failure

Detailed Description

The study will include retrospective and prospective data of patients with an outpatient or inpatient diagnosis of CHF.

The duration of the observation period of an individual patient with CHF is limited by the study period, or the patient's death, and includes the studied retrospective and dynamic prospective parameters. Prospective data of CHF (any stage and FC) subjects are planned to be included sequentially as they appear in inpatient CHF centers and outpatient CHF offices until 12/31/2027 inclusive and further upon extension of the study.

Retrospective data will be provided by chief freelance cardiologists of 33 constituent entities of the Russian Federation (Central Federal District, Ural Federal District, Siberian Federal District, Far Eastern Federal District) (individually, according to agreement)

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Vadim Yu Kuznetsov, PhD; Phone Number: +74954146249; Email: vykuznetsov@cardio.ru
• Study Contact Backup: Name: Olga N Svirida, MD, PhD; Phone Number: +74954146552; Email: ONSvirida@Cardio.ru

Study Locations

• Russia
  • Moscow, Russia
    • Recruiting
    • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Organization
    • Contact: Olga N Svirida, MD, PhD; Email: ONSvirida@Cardio.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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

Description

Inclusion Criteria:

• Any stage and/or any class of CHF

Exclusion Criteria:

• Subjects whose source records cant be obtained for the analysis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Proportion of subjects who died from CV causes*		Every 12 months, up to 3 years
Proportion of subjects with different causes of death*		Every 12 months, up to 3 years
Incidence and event rates (per 100 subject-years) for hospitalizations due to HF*		Every 12 months, up to 3 years
Incidence and event rates (per 100 subject-years) for death from CV causes*		Every 12 months, up to 3 years
Incidence and event rates (per 100 subject-years) for death from any cause*		Every 12 months, up to 3 years
The proportion of subjects with preferential drug provision for cardiovascular disease, diabetes mellitus*		Every 12 months, up to 3 years
Average frequency of outpatient visits of subjects with CHF to medical institutions*		Every 12 months, up to 3 years
The proportion of subjects registered with a cardiologist or therapist with different phenotypes and stages of CHF*		Every 12 months, up to 3 years
Average frequency of telephone patronage *	*- in the overall sample and in groups of subjects with HFrEF, HFmrEF, HFpEF and in different age categories (18-49 years; 50-64 years; 65-74 years; 75-85 years;>85 years); of working/non-working age; employed/non-employed	Every 12 months, up to 3 years

Collaborators and Investigators

• Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
• Investigators: Study Chair: Sergey A Boytsov, Prof., E.I.Chazov Cardiology Center; Study Director: Zoya N Blankova, MD, PhD, E.I.Chazov Cardiology Center; Principal Investigator: Fail' T Ageev, Prof., E.I.Chazov Cardiology Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HOSTa CHF; ХОСТА ХСН (Other Identifier: Russian equivalent)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No