National Heart Failure Registry
- Conditions
- Chronic Heart Failure
- Registration Number
- NCT06683001
- Lead Sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- 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.
- 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20000
- Any stage and/or any class of CHF
- Subjects whose source records cant be obtained for the analysis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 * 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
Trial Locations
- Locations (1)
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Organization
🇷🇺Moscow, Russian Federation