A Phase 4 interventional study of Hypertonic Saline (3% Sodium Chloride) and Furosemide (Diuretic) in Acute Heart Failure (AHF) and Acute Decompensated Heart Failure, sponsored by University of Alberta. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Alberta · Phase 4, Interventional, and Treatment
DESAL-HEART is a multicenter, randomized, open-label, blinded-endpoint, mechanistic proof-of-concept trial conducted within the Heart Failure Efficacy and Research Trial (HEART) Platform. The study will evaluate whether adding a single infusion of 3% hypertonic saline solution (HSS) to a pre-declared intravenous furosemide dose improves decongestion in patients hospitalized with acute heart failure.
Background and Rationale
Congestion is a major cause of hospitalization in patients with acute heart failure. Intravenous loop diuretics, such as furosemide, are the standard treatment for removing excess fluid, but treatment responses vary and residual congestion remains common.
Hypertonic saline may temporarily increase effective circulating blood volume, improve kidney perfusion, and enhance the delivery and effectiveness of furosemide. Although previous studies have suggested potential benefits, limitations in study quality and differences in treatment regimens have prevented definitive conclusions.
DESAL-HEART is designed to isolate the effect of hypertonic saline by ensuring that the furosemide dose is determined before randomization and administered in both treatment groups.
Study Design
A total of 60 adults hospitalized with acute heart failure and persistent congestion will be randomized in a 1:1 ratio to receive either:
A single 150 mL infusion of 3% hypertonic saline administered over 30 minutes together with a pre-declared intravenous furosemide dose; or
The same pre-declared intravenous furosemide dose alone.
Randomization will be performed centrally using REDCap, with stratification by chronic kidney disease status. The study is open-label because the control group will not receive a placebo infusion. Laboratory endpoints will be assessed objectively.
The treating clinician will determine and document the intravenous furosemide dose before randomization. Subsequent heart failure management will remain at the discretion of the treating physician.
Study Objectives and Assessments
The primary objective is to estimate the effect of hypertonic saline on NT-proBNP, a biomarker of heart failure, measured 24 ± 6 hours after randomization.
The key mechanistic secondary endpoint is spot urine sodium concentration measured 90-150 minutes after randomization, providing an early measure of the kidneys' response to diuretic treatment.
Additional assessments include:
NT-proBNP at 48 ± 6 hours after randomization.
Spot urine sodium from the first urine sample collected more than 6 hours after randomization.
Changes in body weight, hemoglobin, hematocrit, serum electrolytes, and creatinine at 24 hours.
Urine output, net fluid balance, and additional decongestive treatments during the first 24 hours.
Treatment delivery, recruitment feasibility, and completeness of outcome assessments.
Safety assessments will include infusion intolerance, clinically important electrolyte abnormalities, changes in kidney function, symptomatic hypotension, worsening respiratory status, and serious adverse events. A serum sodium increase of at least 5 mmol/L from baseline or any sodium value of at least 150 mmol/L is a prespecified adverse event of special interest.
Exploratory outcomes include major adverse kidney events and days alive and out of hospital at 30 days. Additional clinical and patient-reported outcomes will be collected through the HEART Platform.
Statistical Analysis and Study Purpose
The primary analysis will use a mixed model for repeated measures to compare log-transformed NT-proBNP at 24 and 48 hours between treatment groups, adjusting for baseline NT-proBNP, site, chronic kidney disease status, age, and sex. The treatment effect will be reported as a geometric mean ratio with a 95% confidence interval.
This 60-participant study is intended to estimate the magnitude and precision of the biological treatment effect rather than establish clinical efficacy. A prespecified Green/Yellow/Red decision framework will integrate the biological signal, urine sodium response, safety, and feasibility to determine whether further investigation in a definitive clinical outcomes trial is warranted.
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 →University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Primary diagnosis of acute heart failure with dyspnea and at least two of the following signs of congestion:
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single 150 mL intravenous infusion of 3% hypertonic saline over 30 minutes, administered concurrently with a pre-declared intravenous furosemide dose. The furosemide dose will be determined by the treating clinician before randomization. Subsequent treatment will follow standard clinical care.
Drug: Hypertonic Saline (3% Sodium Chloride) · Drug: Furosemide (Diuretic)
Participants will receive a pre-declared intravenous furosemide dose without hypertonic saline. The furosemide dose will be determined by the treating clinician before randomization using the same dosing approach as the intervention group. Subsequent treatment will follow standard clinical care.
Drug: Furosemide (Diuretic)
A single 150 mL intravenous infusion of 3% sodium chloride (hypertonic saline solution) administered over 30 minutes, initiated at the same time as the pre-declared intravenous furosemide dose.
A single intravenous dose of furosemide determined and documented by the treating clinician before randomization. The same pre-declared dosing approach applies to both treatment groups. Subsequent diuretic treatment is determined by the treating physician according to standard clinical care.
Change From Baseline in NT-proBNP at 24 Hours
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline to 24 hours after randomization. NT-proBNP is a blood biomarker of heart failure.
Time frame: Baseline to 24 hours after randomization
Spot Urine Sodium Concentration at 90-150 Minutes
Spot urine sodium concentration measured 90-150 minutes after randomization to assess the early natriuretic response to intravenous furosemide with or without hypertonic saline.
Time frame: 90-150 minutes after randomization
Change From Baseline in NT-proBNP at 48 Hours
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline to 48 hours after randomization to assess the persistence of the treatment effect on this heart failure biomarker
Time frame: Baseline to 48 hours after randomization
Spot Urine Sodium Concentration at 6 Hours
Spot urine sodium concentration measured from the first urine sample collected more than 6 hours after randomization to assess the sustained natriuretic response to treatment. The actual sample collection time will be recorded.
Time frame: First urine void more than 6 hours after randomization
Change From Baseline in Hemoglobin at 24 Hours
Change in blood hemoglobin concentration from baseline to 24 hours after randomization, measured using routine complete blood count testing.
Time frame: Baseline and 24 hours after randomization
Change From Baseline in Hematocrit at 24 Hours
Change in hematocrit from baseline to 24 hours after randomization, measured using routine complete blood count testing
Time frame: Baseline and 24 hours after randomization
Change From Baseline in Body Weight at 24 Hours
Change in body weight from baseline to 24 hours after randomization to assess fluid removal and decongestion.
Time frame: Baseline and 24 hours after randomization
Total Urine Output Through 24 Hours
Total recorded urine output during the first 24 hours after randomization to assess the diuretic response to treatment.
Time frame: Randomization through 24 hours
Net Fluid Balance Through 24 Hours
Net fluid balance, calculated as total recorded fluid intake minus total recorded fluid output during the first 24 hours after randomization.
Time frame: Randomization through 24 hours
Total Furosemide-Equivalent Dose Through 24 Hours
Total furosemide-equivalent diuretic dose administered during the first 24 hours after randomization, including the pre-declared study dose and subsequent diuretic treatments.
Time frame: Randomization through 24 hours
Other Decongestive Therapies Through 24 Hours
Use of additional decongestive therapies during the first 24 hours after randomization, including treatments administered at the discretion of the treating physician.
Time frame: Randomization through 24 hours
Change From Baseline in Serum Sodium
Change in serum sodium concentration from baseline to 24 hours after randomization.
Time frame: Baseline and 24 hours
Change From Baseline in Serum Chloride
Change in serum chloride concentration from baseline to 24 hours after randomization.
Time frame: Baseline and 24 hours
Change From Baseline in Serum Potassium
Change in serum potassium concentration from baseline to 24 hours after randomization.
Time frame: Baseline and 24 hours
Change From Baseline in Serum Bicarbonate
Change in serum bicarbonate concentration from baseline to 24 hours after randomization.
Time frame: Baseline and 24 hours
Change From Baseline in Serum Creatinine
Change in serum creatinine concentration from baseline to 24 hours after randomization to assess kidney function.
Time frame: Baseline and 24 hours
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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