Not Yet RecruitingPhase 3

Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal

60 participantsStarted 2026-05-01

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial combines hypertonic saline with a loop diuretic taken at home rather than in the hospital — is my current heart failure and kidney disease stable enough that outpatient diuretic treatment like this would even be considered safe for me?
2The trial is measuring rehospitalization for heart failure and all-cause mortality as its main outcomes — given my specific situation, does my doctor think reducing hospital readmissions is the most pressing goal right now, or are there other priorities that standard inpatient care might address better?
3Since this trial is Phase 3 but hasn't started recruiting yet, how long might it be before I could actually enroll, and should I be pursuing other treatment options in the meantime rather than waiting?
4Hypertonic saline combined with loop diuretics can affect fluid and electrolyte balance — given my kidney disease, what risks to my kidney function would my doctor want me to understand before considering a treatment approach like this one?
5Are there already-approved outpatient diuretic strategies my doctor would recommend first, or does the combination being tested in this trial represent something meaningfully different from what I could access outside of a clinical trial right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants rehospitalized for heart failure

Timeframe: 30 days and 60 days

All-cause mortality

Timeframe: 30 days and 60 days

Trial details

NCT IDNCT07596329

SponsorUniversity of Monastir

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-30

View on ClinicalTrials.gov More Heart Failure trials