[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622223":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":16,"locations":7,"responsibleParty":26,"collaborators":7,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":34,"eligibilityCriteria":35,"healthyVolunteers":30,"sex":36,"minAge":37,"maxAge":7,"enrollmentInfo":38,"targetDuration":7,"studyType":41,"phases":7,"briefSummary":42,"conditions":43,"keywords":46,"overallStatus":51,"whyStopped":7,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":7},{"fullName":5,"class":6},"Russian Scientific Medical Society of Therapists","OTHER",null,[9,13],{"name":10,"affiliation":11,"role":12},"Oxana Drapkina, doctor of sciences","National Medical Research Center for Terapy and Preventive Medicine","STUDY_CHAIR",{"name":14,"affiliation":15,"role":12},"Anna Chesnikova, doctor of sciences","Rostov-on-Don State Medical Univercity",[17,22],{"name":18,"role":19,"phone":20,"phoneExt":7,"email":21},"Anjela E Soloveva, Phd","CONTACT","+7 915 376 6940","anzhela.solovieva@gmail.com",{"name":23,"role":19,"phone":24,"phoneExt":7,"email":25},"Alexandr Gorshkov, phd","+7 916 310 9184","agorshkov@gnicpm.ru",{"type":27,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100622223","cardio-reno--hepato--metabolic-disease-in-chronic-heart-failure-carmen-chf-100622223",false,"NCT07380828","CArdio-Reno- Hepato -MEtabolic Disease iN Chronic Heart Failure (CARMEN-CHF)","Multicenter Observational Prospective Study of Cardio-reno- Hepato -Metabolic Disease in Chronic Heart Failure","CARMEN-CHF","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. A diagnosis that satisfies one of the following criteria:\n\n   * At least one of the following:\n\nLVEF \\\u003C50%, LV longitudinal systolic strain (GLS) \\\u003C18%, NT-proBNP \\>125 pg\u002FmL in sinus rhythm or 365 in AF\u002FAT, E\u002Fé \\>9 at rest by tissue Doppler, Indexed left ventricular volume (ILV) \\>34 mL\u002Fm2 in sinus rhythm or 40 mL\u002Fm2 in AF\u002FAT, Tricuspid regurgitation (TR) velocity \\>2.8 m\u002Fs or pulmonary artery systolic pressure (PASP) \\>35 mmHg. at rest, Left ventricular myocardial mass index (LVMI) \\>115\u002F95 g\u002Fm2 in men\u002Fwomen and relative wall thickness (RWT) \\>0.42, in the absence of symptoms and\u002For signs of current or past CHF, which corresponds to \"pre-CHF\" in accordance with the 2024 clinical guidelines.\n\nor\n\n* LVEF \\\u003C50% and the presence of symptoms and\u002For signs of current or past CHF or\n* LVEF ≥50% and the presence of symptoms and\u002For signs of current or past CHF, as well as at least one of the following (A, B, C) criteria:\n\nA. Presence of one of the signs of structural and\u002For functional heart disorders consistent with the presence of diastolic dysfunction \u002F elevated left ventricular filling pressure:\n\n1. . NT-proBNP level \\>200 pg\u002FmL in sinus rhythm or \\>600 pg\u002FmL in AF\u002FAT,\n2. . E\u002Fé \\>13 at rest by tissue Doppler,\n3. . 13 ≥E\u002Fé \\>9 + left atrial dilation (LAD) \\>34 ml\u002Fm2 in sinus rhythm or \\>40 ml\u002Fm2 in AF\u002FAT,\n4. . 13 ≥E\u002Fé \\>9 + TR velocity \\>2.8 m\u002Fs or PASP \\>35 mmHg at rest,\n5. . 13 ≥E\u002Fé \\>9 + presence of left ventricular hypertrophy, defined as LVMI \\>115 g\u002Fm2 in men and \\>95 g\u002Fm2 in women, WCT \\>0.42, OR B. Presence of 7-9 points on the H2FPEF scale; OR C. Positive diastolic stress test result confirming increased LV filling pressure (E\u002Fe'≥15, TR velocity \\>3.4 m\u002Fs) 3. No intravenous therapy with diuretics, nitrates, vasopressors, or inotropes within 24 hours prior to inclusion; 4. Availability of results of all of the following tests, performed no earlier than in the previous 6 months prior to inclusion in the study:\n\n\\[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\u002For 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\u002Fday) and\u002For albumin\u002Fcreatinine ratio in a single urine portion (mg\u002Fg or mg\u002Fmmol) and\u002For daily proteinuria (g\u002Fday) and\u002For protein\u002Fcreatinine ratio in a single urine portion (mg\u002Fg or mg\u002Fmmol). -\n\nExclusion Criteria:\n\n* 1\\. Current participation in a randomized clinical trial; 2. Confirmed or suspected diagnosis of an alternative or comorbid condition that, in the opinion of the investigator, may explain the patient's symptoms and signs of CHF; 3. History of heart transplantation, combined congenital heart disease, or the presence of a mechanical circulatory support device; 4. Cardiac tamponade; 5. Pregnancy and lactation, planning a pregnancy in the next 24 months; 6. Acute cerebrovascular accident, transient ischemic attack, acute coronary syndrome, or coronary revascularization within less than 30 days prior to or on the day of study inclusion; 7. Acute dysfunction or failure of one or more internal organs within 3 months prior to or on the day of inclusion; 8. Any cardiac surgery performed within 3 months prior to enrollment or planned within the next 6 months, including implantation of intracardiac devices, ablation for cardiac arrhythmias, or correction of valvular pathology; 9. Severe cognitive impairment or other conditions that, in the opinion of the investigator, prevent the patient from understanding the program, providing informed consent, or interfere with participation in the study; 10. Active cancer; 11. Verified cardiac amyloidosis or other infiltrative cardiomyopathy (hemochromatosis, Fabry disease, Gaucher disease); 12. Verified hereditary cardiomyopathy; 13. Heart disease due to reversible causes (e.g., Takotsubo syndrome).","ALL","18 Years",{"count":39,"type":40},3000,"ESTIMATED","OBSERVATIONAL","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.",[44,45],"Heart Failure","Cardio-renal-metabolic Syndrome",[47,48,49,50],"obesity","atherosclerosis","type 2 diabetes mellitus","heart failure","NOT_YET_RECRUITING","2026-01-24",{"date":54,"type":55},"2026-02-02","ACTUAL",{"date":57,"type":40},"2026-02",{"date":59,"type":40},"2029-05",{"name":5,"class":6}]