A Phase 3 interventional study of Hypertonic sodium chloride 10% and Sodium Chloride 0.9% in Heart Failure and Renal Disease, Chronic, sponsored by University of Monastir. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by University of Monastir · Phase 3, Interventional, and Treatment
Among 16 studies in Heart Failure by University of Monastir — 4 open to participants now, 5 under way, 1 of them phase 3. Heart Failure · University of Monastir.
Among the 16 studies in Heart Failure by University of Monastir, this one is one of 3 that started in 2026, is one of 2 in phase 3, and was the 15th registered.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 60 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →4 of the 16 studies in Heart Failure by University of Monastir are open now, in 1 country. Each count lists the studies.
Of the 968 Heart Failure studies recruiting now, 691 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 64 take children under 18; 96 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →16 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 3 started in 2026.
Median enrollment 125 across the 4 interventional studies, 550 across the 12 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.
University of Monastir is the lead sponsor of 114 studies on the registry; 29 are open to participants now.
2 of the studies in Heart Failure by University of Monastir that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07596329Phase 3University of MonastirOutpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal | 2027-11-30 |
| NCT07345156University of MonastirCongestion and LActate at diScHarge in Acute Heart Failure | 2026-12-30 |
Among the 16 studies in Heart Failure by University of Monastir, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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.
Drug: Hypertonic sodium chloride 10% · Drug: Furosemide intravenous solution
* 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.
Drug: Sodium Chloride 0.9% · Drug: Furosemide intravenous solution
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.
Number of participants rehospitalized for heart failure
Description: Number of participants requiring rehospitalization for heart failure during follow-up.
Time frame: 30 days and 60 days
All-cause mortality
Description: Number of deaths from any cause during follow-up.
Time frame: 30 days and 60 days
Serum creatinine level
Evaluation of serum creatinine levels.
Time frame: 30 days 60 days
Blood urea level
Evaluation of blood urea levels.
Time frame: 30 days 60 days
BNP or NT-proBNP concentration
Evaluation of BNP or NT-proBNP levels.
Time frame: 30days 60 days
Quality of life and patient satisfaction score assessed using a Likert scale
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.
Time frame: 30 days and 60 days
No study locations are listed for this record.
Plan to share: No — PD will not be shared due to concerns related to patient confidentiality and data privacy
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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