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NCT Number: NCT07596329

Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypertonic sodium chloride 10%

Drug

50 mL of 10% hypertonic sodium chloride (NaCl)

Sodium chloride 0.9%

Drug

50 mL of 0.9% sodium chloride (NaCl)

Furosemide intravenous solution

Drug

Furosemide 250 mg administered intravenously over 60 minutes once weekly for 2 months.

Primary outcomes

  1. Number of participants rehospitalized for heart failure

    Time frame: 30 days and 60 days

    Description: Number of participants requiring rehospitalization for heart failure during follow-up.

  2. All-cause mortality

    Time frame: 30 days and 60 days

    Description: Number of deaths from any cause during follow-up.

Secondary outcomes

  1. Serum creatinine level

    Time frame: 30 days 60 days

    Evaluation of serum creatinine levels.

  2. Blood urea level

    Time frame: 30 days 60 days

    Evaluation of blood urea levels.

  3. BNP or NT-proBNP concentration

    Time frame: 30days 60 days

    Evaluation of BNP or NT-proBNP levels.

  4. Quality of life and patient satisfaction score assessed using a Likert scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Acronym: SALT-HF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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