Oral Sodium to Preserve Renal EfficiencY in Acute Heart Failure

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Volume Overload

In brief

The investigators are proposing a prospective, randomized, double blinded, placebo-controlled single center study evaluating the role of co-administration of oral sodium chloride (NaCl) with intravenous diuretics in patients hospitalized with acute decompensated heart failure. The investigators are approaching this study with the hypothesis that the use of oral sodium chloride leads to improved effective diuresis (as measured by weight loss) and renal function as compared to placebo in patients hospitalized with acute decompensated heart failure undergoing aggressive intravenous diuretic therapy.

Key facts

Study ID

NCT04334668

Run by

The Cleveland Clinic

People needed

67

Starts

2020-05-20

Expected to finish

2026-12-31

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old AND
• Admitted to cardiology floor (non-ICU) with primary diagnosis of decompensated heart failure AND
• NT-proBNP >1000 ng/L AND
• Initiation of continuous furosemide infusion at a rate of 10 mg/hr or higher

You may not qualify if…

• Serum sodium (Na+) level less than 120 or greater than 145.
• Average Systolic Blood Pressure >180 mmHg or Diastolic Blood Pressure >100 mmHg over past 24 hours.
• Anticipated length of stay less than 72 hours.
• Use of vasopressin antagonist
• Current use of sodium chloride tablets
• Active diagnosis of diabetes insipidus
• Inability to tolerate oral diet or swallow pills
• Presence of malabsorptive gastrointestinal disorder (Crohn's disease, short gut syndrome)
• The use of iodinated radiocontrast material in the past 72 hours or anticipated use of intravenous contrast during the current hospitalization
• Admission with intention to transplant or implant permanent Ventricular Assistive Device
• Use of intravenous inotropes, vasopressors or vasodilators at enrollment
• A baseline estimated glomerular filtration rate <15 mL/min/1.73m² according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at the moment of inclusion
• Use of renal replacement therapy at time of enrollment

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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