[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Russian Scientific Medical Society of Therapists\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"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":20,"type":21},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.",[25,26],"Heart Failure","Cardio-renal-metabolic Syndrome",[28,29,30,31],"obesity","atherosclerosis","type 2 diabetes mellitus","heart failure","NOT_YET_RECRUITING","2026-01-24",{"date":35,"type":36},"2026-02-02","ACTUAL",{"date":38,"type":21},"2026-02",{"date":40,"type":21},"2029-05",{"name":42,"class":43},"Russian Scientific Medical Society of Therapists","OTHER",""]