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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.
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| Measure | Description | Time Frame |
|---|---|---|
| the proportion of patients with the presence ofCardio-Kidney-Metabolic (CKM) Syndrome its components and their combinations | 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). | From date of enrollment until the date of first documented occurrence assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Age ≥18 years;
A diagnosis that satisfies one of the following criteria:
LVEF <50%, LV longitudinal systolic strain (GLS) <18%, NT-proBNP >125 pg/mL in sinus rhythm or 365 in AF/AT, E/é >9 at rest by tissue Doppler, Indexed left ventricular volume (ILV) >34 mL/m2 in sinus rhythm or 40 mL/m2 in AF/AT, Tricuspid regurgitation (TR) velocity >2.8 m/s or pulmonary artery systolic pressure (PASP) >35 mmHg. at rest, Left ventricular myocardial mass index (LVMI) >115/95 g/m2 in men/women and relative wall thickness (RWT) >0.42, in the absence of symptoms and/or signs of current or past CHF, which corresponds to "pre-CHF" in accordance with the 2024 clinical guidelines.
or
A. Presence of one of the signs of structural and/or functional heart disorders consistent with the presence of diastolic dysfunction / elevated left ventricular filling pressure:
[1] Complete blood count with hemoglobin and platelet levels, [2] Blood chemistry with total bilirubin, ALT, and AST levels, [3] Serum uric acid and creatinine levels, with glomerular filtration rate (eGFR) calculation using the 2021 CKD-EPI formula, [4] Fasting glucose and HbA1c, and, if the diagnosis is uncertain, an oral glucose tolerance test, [5] Ultrasound of the carotid and/or femoral arteries (only in patients with no prior history of atherosclerotic cardiovascular disease), [6] Urine test for CKD markers - at least one of the following: daily albuminuria (mg/day) and/or albumin/creatinine ratio in a single urine portion (mg/g or mg/mmol) and/or daily proteinuria (g/day) and/or protein/creatinine ratio in a single urine portion (mg/g or mg/mmol). -
Exclusion Criteria:
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The study will include patients with pre-existing or clinically evident CHF at the outpatient stage or in hospital, provided that their condition is stabilized and there has been no intravenous therapy with diuretics, nitrates, vasopressors or inotropes during the previous 24 hours.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anjela E Soloveva, Phd | Contact | +7 915 376 6940 | anzhela.solovieva@gmail.com | |
| Alexandr Gorshkov, phd | Contact | +7 916 310 9184 | agorshkov@gnicpm.ru |
| Name | Affiliation | Role |
|---|---|---|
| Oxana Drapkina, doctor of sciences | National Medical Research Center for Terapy and Preventive Medicine | Study Chair |
| Anna Chesnikova, doctor of sciences | Rostov-on-Don State Medical Univercity | Study Chair |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009765 | Obesity |
| D050197 | Atherosclerosis |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| 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" |
| 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 | From the enrollment to the documented clinically expressed CHF assessed up to 24 months |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |