Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal

Conditions

• Heart Failure
• Renal Disease, Chronic

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

First listed

May 19, 2026

Start date

Sep 1, 2026

Status verified

Jul 2026

Primary completion

Nov 30, 2027

Completion

Dec 30, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Placebo Comparator: 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.

Primary Outcome Measure

Number of participants rehospitalized for heart failure [ Time Frame: 30 days and 60 days ]

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