Hypertonic sodium chloride 10%
Drug50 mL of 10% hypertonic sodium chloride (NaCl)
NCT Number: NCT07596329
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.
Trial opening soon.
Get Notified18 year–90 year
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50 mL of 10% hypertonic sodium chloride (NaCl)
50 mL of 0.9% sodium chloride (NaCl)
Furosemide 250 mg administered intravenously over 60 minutes once weekly for 2 months.
Time frame: 30 days and 60 days
Description: Number of participants requiring rehospitalization for heart failure during follow-up.
Time frame: 30 days and 60 days
Description: Number of deaths from any cause during follow-up.
Time frame: 30 days 60 days
Evaluation of serum creatinine levels.
Time frame: 30 days 60 days
Evaluation of blood urea levels.
Time frame: 30days 60 days
Evaluation of BNP or NT-proBNP levels.
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.
University of Monastir
Other
Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal Syndrome: The SALT-HF Randomized Double-Blind Trial
Acronym: SALT-HF
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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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