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NCT07596329Not yet recruitingPhase 3

Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal

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

Source: ClinicalTrials.gov · Last updated 15 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
60 (estimated)
First submitted
24 Feb 2026
Start date
Sept 2026
Primary completion date
Nov 2027
Lead sponsor
University of Monastir
NCT number
NCT07596329

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 60
  • From Sept 2026 to the primary completion date, Nov 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of allergic reaction to HSS or furosemide

Lab values

  • Severe hyponatremia (\<130 mmol/L) or hypernatremia (\>150 mmol/L),

Other

  • Shock or hemodynamic instability
  • Pregnancy or breastfeeding
  • Chronic dialysis treatment
  • Patient refusal or withdrawal of consent

Who the study is looking for

  • Age ≥ 18 years
  • Chronic renal insufficiency (serum creatinine \> 150 µg/ml)
  • Diagnosis of heart failure (preserved or reduced LVEF)
  • Signed informed consent

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.