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NCT Number: NCT06683001

National Heart Failure Registry

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.

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Key information

Conditions

Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Moscow, Russia

Location status: Recruiting

Location contact

Olga N Svirida, MD, PhD

CONTACT

[email protected]

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any stage and/or any class of CHF

Exclusion criteria

  • Subjects whose source records cant be obtained for the analysis

Treatment and study plan

Primary outcomes

  1. Age of subjects with different phenotypes and stages of CHF

    Time frame: Every 12 months, up to 3 years

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

    Time frame: Every 12 months, up to 3 years

  3. Clinical status of subjects with different phenotypes and stages of CHF

    Time frame: Every 12 months, up to 3 years

  4. Proportion of employable and working subjects with different phenotypes and stages of CHF

    Time frame: Every 12 months, up to 3 years

  5. 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)

    Time frame: Every 12 months, up to 3 years

  6. 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)

    Time frame: Every 12 months, up to 3 years

  7. 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

    Time frame: Every 12 months, up to 3 years

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

    Time frame: Every 12 months, up to 3 years

Secondary outcomes

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

    Time frame: Every 12 months, up to 3 years

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

    Time frame: Every 12 months, up to 3 years

  3. Proportion of subjects with newly diagnosed type 2 diabetes*

    Time frame: Every 12 months

  4. Proportion of subjects with deterioration of renal function*

    Time frame: Every 12 months, up to 3 years

  5. Proportion of subjects with newly diagnosed malignant neoplasm*

    Time frame: Every 12 months, up to 3 years

  6. Proportion of subjects who died from CV causes*

    Time frame: Every 12 months, up to 3 years

  7. Proportion of subjects with different causes of death*

    Time frame: Every 12 months, up to 3 years

  8. Incidence and event rates (per 100 subject-years) for hospitalizations due to HF*

    Time frame: Every 12 months, up to 3 years

  9. Incidence and event rates (per 100 subject-years) for death from CV causes*

    Time frame: Every 12 months, up to 3 years

  10. Incidence and event rates (per 100 subject-years) for death from any cause*

    Time frame: Every 12 months, up to 3 years

  11. The proportion of subjects with preferential drug provision for cardiovascular disease, diabetes mellitus*

    Time frame: Every 12 months, up to 3 years

  12. Average frequency of outpatient visits of subjects with CHF to medical institutions*

    Time frame: Every 12 months, up to 3 years

  13. The proportion of subjects registered with a cardiologist or therapist with different phenotypes and stages of CHF*

    Time frame: Every 12 months, up to 3 years

  14. Average frequency of telephone patronage *

    Time frame: Every 12 months, up to 3 years

    *- 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

Study contacts

Contact information is provided by the study sponsor or research team.

Olga N Svirida, MD, PhD

CONTACT

[email protected]

+74954146552

Vadim Yu Kuznetsov, PhD

CONTACT

[email protected]

+74954146249

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 12, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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