Study aims to investigate the incidence, associations and prognostic value of CRGM and its components: chronic kidney disease, type 2 diabetes, atherosclerotic cardiovascular diseases, and non-alcoholic fatty liver disease in patients with different phenotypes and severity of clinical manifestations of CHF.
The CARMEN-CHF study is a multicenter, observational, prospective study of the KRGMB in patients with pre-onset CHF or clinically overt CHF. Patients who meet the study eligibility criteria and consent to participate must provide written informed consent prior to any study-related procedures. By signing the informed consent form, patients grant access to medical information for the purpose of verifying eligibility and collecting information during follow-up. To ensure a representative sample, it is planned to enroll at least 3,000 patients at study centers across Russia. The proportion of patients included based on pre-onset CHF will be limited to 25% of the entire cohort. The study's follow-up period is 24 months, during which four visits are planned: two telephone visits at 6 and 18 months, and two in-person visits at 12 and 24 months. If it is not possible to visit a doctor in person, it is permissible to collect information through telephone contacts with the patient or his relative or person caring for the patient.
Study Type
OBSERVATIONAL
Enrollment
3,000
the proportion of patients with the presence ofCardio-Kidney-Metabolic (CKM) Syndrome its components and their combinations
Time frame: From date of enrollment until the date of first documented progression assessed up to 24 months
the proportion of patients with the presence ofCardio-Kidney-Metabolic (CKM) Syndrome its components and their combinations
the frequency of occurrence, associations and prognostic value of Cardio-Kidney-Metabolic (CKM) Syndrome and its components (CKD, T2DM, ASCVD and MAFLD) in patients with different phenotypes (hereinafter phenotypes - CHF with reduced, moderately reduced and preserved LVEF) and severity of clinical manifestations of CHF (hereinafter severity of clinical manifestations of CHF - pre-CHF, functional class (FC) I-II and III-IV).
Time frame: From date of enrollment until the date of first documented occurrence assessed up to 24 months
the proportion of patients developing adverse outcomes after 6, 12 and 24 months of follow-up
Determine the proportion of patients developing adverse outcomes after 6, 12, and 24 months of follow-up: * cardiovascular death, * hospitalization due to decompensated CHF, * total number of episodes of CHF worsening, including hospitalizations due to decompensated CHF and outpatient worsening of CHF, * death from any cause, * death from any cause or hospitalization due to decompensated CHF, * hospitalization for any cause, * any major cardiovascular event (including cardiovascular death, hospitalization due to decompensated CHF, acute myocardial infarction, unplanned revascularization, new-onset atrial fibrillation (AF), device implantation (cardioverter-defibrillator, pacemaker, cardiac resynchronization therapy device), unplanned cardiac surgery valves, acute cerebrovascular accident, revascularization of the carotid or peripheral arteries);
Time frame: From date of enrollment until the date of first documented cardiovascular death, • hospitalization due to decompensated CHF, • total number of episodes of CHF worsening, including hospitalizations due to , whichever came first, assessed up to 24 months"
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frequency of transition from pre-CHF to clinically expressed CHF
frequency of transition from pre-CHF to clinically expressed CHF depending on the initial signs of systolic or diastolic dysfunction of the left ventricle, the initial presence of 1, 2, 3 or 4 components of the CRGM, the therapy being administered
Time frame: From the enrollment to the documented clinically expressed CHF assessed up to 24 months