This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated heart failure (ADHF).
Subjects will be recruited from the Emergency Department. It is expected that subjects will be treated according to the institution's accepted conventional therapy protocol for the treatment of ADHF. Therapy may also include the use of loop diuretics for the relief of pulmonary congestion and maintenance of adequate urine output.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
9
Premix bag
Premix bag
Unnamed facility
Hyderabaad, India
Unnamed facility
Karnāl, India
Unnamed facility
New Delhi, India
Unnamed facility
New Delhi, India
Change in Renal Function From Baseline at 72 Hours Assessed by Calculated Creatinine Clearance (MDRD Equation)
MDRD = Modification of Diet in Renal Disease The MDRD equation is a standard calculation for estimated glomerular filtration rate. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Time frame: Baseline and 72 Hours
Assessment of Dyspnea at 24 Hours as Determined by a 7-point Likert Scale
Dyspnea is defined as the sensation of uncomfortable or difficult breathing. Changes in Dyspnea were assessed using the following 7-point scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Time frame: 24 Hours
Change in Renal Function From Baseline at Hours 24, 48 and 72 as Assessed by Urine Creatinine Clearance
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Time frame: Baseline, 24 Hours, 48 Hours and 72 Hours
Change in Renal Function From Baseline at Hours 24, 48 and Day 9 (or Day of Discharge) as Assessed by Serum Creatinine Concentration and Calculated Creatinine Clearance
Calculated creatinine clearance is only calculated through hour 72 using the MDRD equation. MDRD = Modification of Diet in Renal Disease The MDRD equation is a standard calculation for estimated glomerular filtration rate. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Time frame: Baseline, 24 Hours, 48 Hours and Day 9
Incidence of Use of Rescue Therapy or Other Intervention (Including Dialysis) Because of Worsening Renal Function
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
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Time frame: Day 9
Termination of Study Drug Due to an Adverse Event or Intolerability
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Time frame: 48.5 Hours
Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Relative Dyspnea Assessment
Dyspnea is defined as the sensation of uncomfortable or difficult breathing. Changes in Dyspnea were assessed using the following 7-point Likert scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Time frame: Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours
Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Provocative Dyspnea Assessment
Dyspnea is defined as the sensation of uncomfortable or difficult breathing. The Provocative Dyspnea Assessment assesses dyspnea and changes in dyspnea from Baseline on a 5-point Likert scale at 5 different positions and assigns a Dyspnea Severity Score that ranges from 1 (worst severity) to 25 (least severity). Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Time frame: Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours
Change From Baseline in Body Weight at Hours 24, 48 and 72 and Days 6 and 9 (or Day of Discharge)
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Time frame: Baseline, 24 Hours, 48 Hours, 72 Hours, Day 6 and Day 9
Total Loop Diuretic Use Through 48 Hours
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Time frame: 48 Hours
Total Urine Output at Hours 6, 12, 24, 48 and 72
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Time frame: 6 Hours, 12 Hours, 24 Hours, 48 Hours and 72 Hours