The purpose of this study is to test the use of tolvaptan (commercial name Samsca) when given in addition to intravenous (IV) diuretics early during an episode of acute heart failure. It will be compared to a high dose of IV diuretics alone or the use of metolazone in addition to IV diuretics. The investigators are looking to see if there is improvement in the symptoms and outcomes of persons with acute heart failure.
This is a single-center, randomized trial to assess the effects of 30 mg daily of tolvaptan when given concomitantly with home dose of diuretic (Lasix equivalent) intravenously (IV) versus 5mg daily of metolazone given concomitantly with home dose of diuretic (Lasix equivalent) IV, versus 2.5 times home dose of diuretic (Lasix equivalent) IV in participants hospitalized for acutely decompensated heart failure (ADHF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Participants will receive oral daily tolvaptan 30 mg concomitantly with their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.
Participants will receive oral daily metolazone 5 mg concomitantly with their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.
Participants will receive two and a half (2.5) times their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Length of Hospitalization Measured in Days
The number of days hospitalized until discharge.
Time frame: Duration of Hospitalization (Average of Five Days)
Change in Body Weight
The difference in body weight from hospital admission to discharge measured in kilograms.
Time frame: Baseline (hospital admission), Discharge (Average of 5 Days)
Total Diuretic Dose
The total dose of diuretics given throughout the duration of hospitalization measured in milligrams (mg).
Time frame: Up to Five Days
Change in estimated glomerular filtration rate (eGFR)
The difference in eGFR from baseline (hospital admission) to discharge.
Time frame: Baseline (hospital admission), Discharge (Average of 5 days)
Number of Days Alive
The number of days participants remain alive over thirty days after hospital discharge.
Time frame: Post Hospital Discharge (30 days)
Rate of Re-Hospitalization
The number of participants re-hospitalized for worsening heart failure or death at 30 days.
Time frame: 30 Days Post Hospitalization
Number of Electrolyte Imbalance Related Adverse Events
The number of adverse events due to electrolyte imbalance throughout the duration of hospitalization.
Time frame: Duration of Hospitalization (Average of Five Days)
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Number of Participants Requiring Electrolyte Repletion
The number of participants that require electrolyte repletion throughout the duration of hospitalization.
Time frame: Duration of Hospitalization (Average of Five Days)
Change in Sodium Level
The difference in sodium levels from baseline to hospital discharge measured in milliequivalents per liter (mEqL).
Time frame: Baseline (hospital admission), Discharge (Average of 5 days)