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临床试验/NCT04778787
NCT04778787已完成4 期

Impact of Sodium-glucose Cotransporter Type 2 Inhibitors on the Course of Cardiorenal Syndrome in Acute Decompensation of Chronic Heart Failure

I.M. Sechenov First Moscow State Medical University2 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
370
试验地点
2
主要终点
death due to heart failure

研究概览

简要总结

The effect of sodium-glucose cotransporter type 2 inhibitors (SGLT2i) on the parameters of renal function in acute decompensation of chronic heart failure (ADHF) compared to standard therapy will be analyzed. Based on the dynamics of the clinical condition, the duration of hospitalization, and blood biochemical parameters (creatinine, urea, uric acid, potassium, sodium, N-terminal pro-brain natriuretic peptide - NT-proBNP) conclusions will be drawn about the possibility of using SGLT2i in this group of patients.

详细描述

This is a randomized multicenter prospective clinical trial involving patients over 18 years of age who were hospitalized due to decompensation of chronic heart failure (CHF).

The aim of the study is to evaluate the effect of SGLT2i on renal function in the treatment of decompensation of chronic heart failure compared to standard therapy.

The study is planned to include 370 patients with decompensated chronic heart failure. The study will be conducted in Сity clinical hospital number 7, University clinical hospital number 1.

Patients will be screened in the first 24 hours from the moment of hospitalization, inclusion and exclusion criteria will be applied. The ADHF diagnosis was made based on 1) presence of congestion (based on the presence of dyspnoea and at least two of the following:congestion on chest X-ray in straight and side projections with radiation load 0,1 mSv (СombiDiagnost R90, №2017/6644), rales on chest auscultation, peripheral edema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) 2) the need for intravenous administration of loop diuretics.

The diagnosis will be confirmed by echocardiography (ECHO) (Ge Logic F6; №9451\61287) to assess systolic (a decrease in LV ejection fraction (LVEF) <50%) and diastolic dysfunction (ratio of early diastolic transmitral E flow to the average early diastolic velocity of the fibrous ring e´ >14; left atrial volume index (LAVI) >34 ml/m2; the maximum speed of tricuspid regurgitation >2.8 m/s ( American Society of Echocardiography (ASE)/European Association of Cardiovascular Imaging (EACVI) recommendations)[11]) and the presence of an enlarged, non-collapsing on inspiration inferior vena cava (IVC).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

the intervention group

Experimental

The intervention group includes patients with decompensated chronic heart failure. The diagnosis will be made according to the criteria described above

干预措施: Standard list of drugs used for acute decompensation of CHF (loop diuretics, vasodilators, digoxin, inotropic agents, vasopressors), plus dapagliflozin (Forxiga; MP-002596) (Drug)

the control group

Experimental

The control group will be identical to the main group.

干预措施: Standard list of drugs used for acute decompensation of CHF (loop diuretics, vasodilators, digoxin, inotropic agents, vasopressors), plus dapagliflozin (Forxiga; MP-002596) (Drug)

结局指标

主要结局

death due to heart failure

时间窗: through study completion, an average of 5 days

Death during hospitalization

次要结局

  • deterioration of renal function (increase in blood creatinine by 0.3 mg / dl within 48 hours)(through study completion, an average of 5 days)
  • development of resistance to diuretics(through study completion, an average of 5 days)
  • re-hospitalization about decompensation of chronic heart failure within 30 days after discharge from the hospital(up to 30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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