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SURE-HF: Urinary Sodium-Guided Diuretic Therapy in Heart Failure (SURE-HF)

2026年6月1日 更新者：Nurgul Ablakimova

Urinary Sodium-Guided Optimization of Diuretic Therapy in Patients With Worsening Heart Failure: Rationale and Design of a Pragmatic Randomized Controlled Trial (SURE-HF Trial)

The SURE-HF trial is a pragmatic, multicentre, randomized controlled study evaluating natriuresis-guided optimization of intravenous loop diuretic therapy in patients hospitalized with worsening heart failure (WHF). The study aims to determine whether serial urinary sodium assessment combined with a structured decongestive treatment algorithm improves decongestion, reduces the need for therapy escalation, and enhances discharge readiness compared with standard care.

Participants will be randomized to standard urine output-guided therapy or natriuresis-guided decongestive strategies using different intravenous loop diuretic administration regimens. The study integrates bedside diagnostic tools including lung ultrasound, inferior vena cava assessment, focused echocardiography, and serial clinical congestion monitoring.

The primary endpoint is a hierarchical composite outcome including escalation of heart failure therapy, persistent congestion at discharge, inability to transition to oral loop diuretics by Day 5, and residual ultrasound congestion. The findings of the SURE-HF trial may support implementation of urinary sodium-guided and ultrasound-assisted decongestive therapy in routine heart failure management.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

260

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age ≥18 years.
  • Confirmed diagnosis of worsening heart failure (WHF), characterized by symptoms and signs of acute decompensation requiring hospitalization for intensification of intravenous diuretic therapy.
  • Previous intake of a loop diuretic (torasemide or furosemide) in any dose for at least 2 days before hospitalization.
  • Presence of clinical signs and symptoms of congestion (e.g., dyspnea, orthopnea, peripheral edema, pulmonary congestion).
  • Provision of written informed consent.

Exclusion Criteria:

  • Acute coronary syndrome within the previous 30 days.
  • Acute heart failure requiring urgent invasive intervention, including cardiogenic shock or mechanical circulatory support.
  • Current admission to an intensive care unit.
  • Systolic blood pressure ≤90 mmHg or requirement for inotropic/vasopressor support.
  • Recent use (≤48 hours) of inotropic agents affecting fluid and electrolyte balance.
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or requirement for renal replacement therapy.
  • Hypokalemia (<3.5 mmol/L) or hyperkalemia (≥5.5 mmol/L).
  • Clinically significant hyponatremia (<130 mmol/L) or hypernatremia (>150 mmol/L).
  • Significant comorbidities affecting sodium-water balance (e.g., liver cirrhosis with ascites, nephrotic syndrome, severe infection or sepsis).
  • Pregnancy or breastfeeding.
  • Active malignancy.
  • Inability to comply with the study protocol or participation in another interventional clinical trial.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Standard Treatment
Standard urine output-guided decongestive therapy according to institutional practice and predefined treatment protocols.
药品：Furosemide
Intravenous loop diuretic therapy administered according to predefined treatment algorithms, including intermittent bolus administration, continuous infusion, or prolonged intermittent infusion with protocol-driven dose titration.
实验性的：Natriuresis-Guided Intermittent IV Bolus
Natriuresis-guided decongestive therapy using intermittent intravenous bolus administration of furosemide with dose titration based on urinary sodium assessment.
药品：Furosemide
Intravenous loop diuretic therapy administered according to predefined treatment algorithms, including intermittent bolus administration, continuous infusion, or prolonged intermittent infusion with protocol-driven dose titration.
设备：Horiba LAQUAtwin B-722
Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.
实验性的：Natriuresis-Guided Continuous Infusion
Natriuresis-guided decongestive therapy using continuous intravenous furosemide infusion via infusion pump with dose titration based on urinary sodium assessment.
药品：Furosemide
Intravenous loop diuretic therapy administered according to predefined treatment algorithms, including intermittent bolus administration, continuous infusion, or prolonged intermittent infusion with protocol-driven dose titration.
设备：Horiba LAQUAtwin B-722
Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.
实验性的：Natriuresis-Guided Prolonged Intermittent Infusion
Natriuresis-guided decongestive therapy using prolonged intermittent intravenous furosemide infusion with dose titration based on urinary sodium assessment.
药品：Furosemide
Intravenous loop diuretic therapy administered according to predefined treatment algorithms, including intermittent bolus administration, continuous infusion, or prolonged intermittent infusion with protocol-driven dose titration.
设备：Horiba LAQUAtwin B-722
Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Hierarchical Composite Endpoint of Unsuccessful Decongestion
大体时间：From randomization through hospital discharge, assessed up to 14 days.
  1. Escalation of heart failure therapy within the first 5 days of hospitalization.
  2. Persistent clinical congestion at hospital discharge, defined as the presence of at least two of the following: dyspnea at rest, orthopnea, pulmonary rales, peripheral edema, or elevated jugular venous pressure.
  3. Failure to transition from intravenous to oral loop diuretics by Day 5 of hospitalization.
  4. Residual ultrasound congestion at hospital discharge, defined as ≥1 zone with ≥3 B-lines (one positive zone) on each hemithorax using 8-zone scanning
From randomization through hospital discharge, assessed up to 14 days.

次要结果测量

结果测量
措施说明
大体时间
Total and Time-Specific Urinary Sodium Excretion
大体时间：6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.
Urinary sodium excretion measured at 6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.
6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.
Time to Clinical Decongestion
大体时间：From initiation of intravenous loop diuretic therapy until clinical decongestion, assessed up to 14 days.
Time from initiation of intravenous loop diuretic therapy to achievement of clinical decongestion, defined as resolution of clinical signs and symptoms of congestion, including absence of dyspnea at rest, orthopnea, pulmonary rales, peripheral edema, and elevated jugular venous pressure.
From initiation of intravenous loop diuretic therapy until clinical decongestion, assessed up to 14 days.
Length of Hospital Stay
大体时间：From hospital admission to hospital discharge, assessed up to 30 days.
Duration of hospitalization measured as the number of days from hospital admission to hospital discharge.
From hospital admission to hospital discharge, assessed up to 30 days.
Death or Heart Failure Rehospitalization Within 30 Days After Discharge
大体时间：From hospital discharge through 30 days after discharge.
Composite outcome of all-cause mortality or rehospitalization due to worsening heart failure occurring within 30 days after hospital discharge.
From hospital discharge through 30 days after discharge.
Cumulative Urine Output
大体时间：From initiation of intravenous loop diuretic therapy through hospital discharge, assessed up to 14 days.
Total urine output measured during hospitalization.
From initiation of intravenous loop diuretic therapy through hospital discharge, assessed up to 14 days.
Proportion of Patients Achieving Predefined Natriuresis Targets
大体时间：Within 72 hours after initiation of intravenous loop diuretic therapy.
Proportion of patients achieving predefined urinary sodium excretion targets according to the study treatment algorithm during the first 72 hours of hospitalization.
Within 72 hours after initiation of intravenous loop diuretic therapy.

其他结果措施

结果测量
措施说明
大体时间
Incidence of Symptomatic Hypotension
大体时间：From randomization through hospital discharge, assessed up to 14 days.
Occurrence of symptomatic hypotension during hospitalization.
From randomization through hospital discharge, assessed up to 14 days.
Clinically Significant Electrolyte Disturbances
大体时间：From baseline through hospital discharge, assessed up to 14 days.
Occurrence of clinically significant abnormalities in serum potassium or sodium during hospitalization.
From baseline through hospital discharge, assessed up to 14 days.
All-Cause In-Hospital Mortality
大体时间：From randomization through hospital discharge, assessed up to 14 days.
Death from any cause occurring during hospitalization.
From randomization through hospital discharge, assessed up to 14 days.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nurgul Ablakimova

合作者

I.M. Sechenov First Moscow State Medical University

调查人员

  • 首席研究员：Nurgul Ablakimova, PhD、West Kazakhstan Marat Ospanov Medical University
  • 研究主任：Vadim Medovchshikov, PhD、West Kazakhstan Marat Ospanov Medical University
  • 首席研究员：Anzhela Soloveva, candidate of medical sciences、I.M. Sechenov First Moscow State Medical University
  • 学习椅：Svetlana Rachina, doctor of medical sciences、I.M. Sechenov First Moscow State Medical University
  • 学习椅：Gaziza Smagulova, candidate of medical sciences、West Kazakhstan Marat Ospanov Medical University
  • 首席研究员：Ayagoz Meshitbayeva、West Kazakhstan Marat Ospanov Medical University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年5月27日

首先提交符合 QC 标准的

2026年6月1日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年6月8日

上次提交的符合 QC 标准的更新

2026年6月1日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 13/2-19-38-7
  • Order №13/2-19-38-7 (其他赠款/资助编号：West Kazakhstan Marat Ospanov medical university)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data underlying the reported results may be shared upon reasonable request to the corresponding author following publication of the primary study results, subject to institutional approval and applicable data protection regulations.

IPD 共享时间框架

De-identified individual participant data and supporting documents will become available beginning 6 months after publication of the primary study results and will remain available for 5 years.

IPD 共享访问标准

Access to de-identified individual participant data and supporting documents will be provided to qualified researchers upon reasonable request to the corresponding author and after approval by the study investigators and participating institution. Data sharing will be limited to non-commercial scientific research purposes and subject to applicable ethical and data protection requirements.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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