Status:
ACTIVE_NOT_RECRUITING
Oral Sodium to Preserve Renal EfficiencY in Acute Heart Failure
Lead Sponsor:
The Cleveland Clinic
Conditions:
Volume Overload
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 intraveno...
Detailed Description
Dietary sodium restriction is a common therapeutic intervention in the management of patients hospitalized with decompensated heart failure. This is despite limited supportive data and inconsistent so...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04334668
Start Date
May 20 2020
End Date
June 1 2026
Last Update
May 4 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195