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NOT YET RECRUITING
NCT07596329
PHASE3

Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal

Sponsor: University of Monastir

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09-01

Completion Date

2027-12-30

Last Updated

2026-07-15

Healthy Volunteers

No

Interventions

DRUG

Hypertonic sodium chloride 10%

50 mL of 10% hypertonic sodium chloride (NaCl)

DRUG

Sodium Chloride 0.9%

50 mL of 0.9% sodium chloride (NaCl)

DRUG

Furosemide intravenous solution

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