Multicenter Observational Prospective Study of Cardio-reno- Hepato -Metabolic Disease in Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,000
- 主要终点
- the proportion of patients with the presence ofCardio-Kidney-Metabolic (CKM) Syndrome its components and their combinations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •A diagnosis that satisfies one of the following criteria:
- •At least one of the following:
- •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.
- •LVEF <50% and the presence of symptoms and/or signs of current or past CHF or
- •LVEF ≥50% and the presence of symptoms and/or signs of current or past CHF, as well as at least one of the following (A, B, C) criteria:
- •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:
- •. NT-proBNP level >200 pg/mL in sinus rhythm or >600 pg/mL in AF/AT,
- •. E/é >13 at rest by tissue Doppler,
- •. 13 ≥E/é >9 + left atrial dilation (LAD) >34 ml/m2 in sinus rhythm or >40 ml/m2 in AF/AT,
- •. 13 ≥E/é >9 + TR velocity >2.8 m/s or PASP >35 mmHg at rest,
- •. 13 ≥E/é >9 + presence of left ventricular hypertrophy, defined as LVMI >115 g/m2 in men and >95 g/m2 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/e'≥15, TR velocity >3.4 m/s)
- •No intravenous therapy with diuretics, nitrates, vasopressors, or inotropes within 24 hours prior to inclusion;
- •Availability of results of all of the following tests, performed no earlier than in the previous 6 months prior to inclusion in the study:
- •[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). -
排除标准
- •1. Current participation in a randomized clinical trial;
- •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;
- •History of heart transplantation, combined congenital heart disease, or the presence of a mechanical circulatory support device;
- •Cardiac tamponade;
- •Pregnancy and lactation, planning a pregnancy in the next 24 months;
- •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;
- •Acute dysfunction or failure of one or more internal organs within 3 months prior to or on the day of inclusion;
- •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;
- •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;
- •Active cancer;
- •Verified cardiac amyloidosis or other infiltrative cardiomyopathy (hemochromatosis, Fabry disease, Gaucher disease);
- •Verified hereditary cardiomyopathy;
- •Heart disease due to reversible causes (e.g., Takotsubo syndrome).
结局指标
主要结局
the proportion of patients with the presence ofCardio-Kidney-Metabolic (CKM) Syndrome its components and their combinations
时间窗: 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
时间窗: From date of enrollment until the date of first documented occurrence assessed up to 24 months
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).
次要结局
- the proportion of patients developing adverse outcomes after 6, 12 and 24 months of follow-up(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(From the enrollment to the documented clinically expressed CHF assessed up to 24 months)