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Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal (SALT-HF)

2026年7月14日 更新者:Pr. Semir Nouira、University of Monastir

Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal Syndrome: The SALT-HF Randomized Double-Blind Trial

Congestive heart failure (CHF) remains a major cause of morbidity, rehospitalization, and mortality worldwide, particularly among elderly and polymorbid patients. Systemic congestion is its most characteristic clinical manifestation and the leading cause of hospitalization for acute heart failure. Standard treatment relies on loop diuretics, primarily furosemide, to reduce fluid overload and alleviate congestive symptoms. However, in clinical practice, many patients exhibit an inadequate diuretic response or resistance to furosemide, particularly in the context of cardiorenal syndrome (CRS), where cardiac and renal dysfunction mutually exacerbate each other. This profile, frequently observed in advanced stages of heart failure, significantly limits the effectiveness of guideline-directed medical therapies (GDMTs), particularly SGLT2 inhibitors, mineralocorticoid receptor antagonists, and angiotensin-converting enzyme (ACE) inhibitors, whose use is often restricted by hypotension, hyperkalemia, or impaired renal function.

Thus, in this subgroup of patients, conventional pharmacological approaches encounter a therapeutic barrier, necessitating the search for alternative or complementary strategies targeting sodium and water depletion without compromising renal perfusion. In this context, the combined administration of hypertonic saline (HS) and furosemide has been proposed as a pathophysiologically sound approach to break the vicious cycle of cardiorenal syndrome. Hypertonic saline solution (HSS) acts by restoring effective intravascular volume, improving renal perfusion, and promoting more efficient natriuresis through better furosemide delivery to the distal nephron. Pioneering studies by Paterna et al. showed that the concomitant administration of HSS (1.4-3% NaCl, 150-250 mL) and intravenous furosemide increased diuresis, improved the hemodynamic profile, and reduced the length of hospital stay and readmission rates without deterioration of renal function.

研究概览

研究类型

介入性

注册 (估计的)

60

阶段

  • 第三阶段

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
  • Chronic renal insufficiency (serum creatinine > 150 µg/ml)
  • Diagnosis of heart failure (preserved or reduced LVEF)
  • Signed informed consent

Exclusion Criteria:

  • Severe hyponatremia (<130 mmol/L) or hypernatremia (>150 mmol/L),
  • History of allergic reaction to HSS or furosemide
  • Shock or hemodynamic instability
  • Pregnancy or breastfeeding
  • Chronic dialysis treatment
  • Patient refusal or withdrawal of consent

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:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:HSS group
  • 50 mL of 10% hypertonic sodium chloride (NaCl) administered intravenously over 60 minutes once weekly for 2 months.
  • Furosemide 250 mg administered intravenously over 60 minutes once weekly for 2 months.
50 mL of 10% hypertonic sodium chloride (NaCl)
Furosemide 250 mg administered intravenously over 60 minutes once weekly for 2 months.
安慰剂比较:placebo group
  • 50 mL of 0.9% sodium chloride (NaCl) administered intravenously over 60 minutes once weekly for 2 months.
  • Furosemide 250 mg administered intravenously over 60 minutes once weekly for 2 months.
Furosemide 250 mg administered intravenously over 60 minutes once weekly for 2 months.
50 mL of 0.9% sodium chloride (NaCl)

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
Number of participants rehospitalized for heart failure
大体时间:30 days and 60 days
Description: Number of participants requiring rehospitalization for heart failure during follow-up.
30 days and 60 days
All-cause mortality
大体时间:30 days and 60 days
Description: Number of deaths from any cause during follow-up.
30 days and 60 days

次要结果测量

结果测量
措施说明
大体时间
Serum creatinine level
大体时间:30 days 60 days
Evaluation of serum creatinine levels.
30 days 60 days
Blood urea level
大体时间:30 days 60 days
Evaluation of blood urea levels.
30 days 60 days
BNP or NT-proBNP concentration
大体时间:30days 60 days
Evaluation of BNP or NT-proBNP levels.
30days 60 days
Quality of life and patient satisfaction score assessed using a Likert scale
大体时间:30 days and 60 days

Description: Assessment of quality of life and patient satisfaction using a 5-point Likert scale ranging from 1 to 5, where:

1 = very dissatisfied/very poor quality of life 5 = very satisfied/excellent quality of life

Higher scores indicate better patient satisfaction and quality of life.

30 days and 60 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。

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9月1日

初级完成 (估计的)

2027年11月30日

研究完成 (估计的)

2027年12月30日

研究注册日期

首次提交

2026年2月24日

首先提交符合 QC 标准的

2026年5月18日

首次发布 (实际的)

2026年5月19日

研究记录更新

最后更新发布 (实际的)

2026年7月15日

上次提交的符合 QC 标准的更新

2026年7月14日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

PD will not be shared due to concerns related to patient confidentiality and data privacy

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

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