A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure

• Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality [ Time Frame: Randomization to Day 30 ] [ Designated as safety issue: Yes ]
  
• Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug [ Time Frame: 6 hours after initiation of study drug ] [ Designated as safety issue: Yes ]
  Dyspnea symptoms were measured by patient self-assessed Likert scale at 6 hours after study drug initiation.The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)
  
  
• Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug [ Time Frame: 24 hours after study drug initiation ] [ Designated as safety issue: Yes ]
  Dyspnea symptoms were measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)
  
  

• Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug [ Time Frame: 6 hours after study drug initiation ] [ Designated as safety issue: Yes ]
  Overall well-being was measured by patient self-assessed Likert scale at 6 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)
  
  
• Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug [ Time Frame: 24 hours after study drug initiation ] [ Designated as safety issue: Yes ]
  Overall well-being was measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)
  
  
• Composite of Persistent or Worsening Heart Failure and All-Cause Mortality [ Time Frame: Randomization to hospital discharge (up to Day 30) ] [ Designated as safety issue: Yes ]
  Clinical manifestations of worsening or persistent decompensated heart failure were defined by at least one of the following: new, persistent or worsening: dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema, pulmonary basilar rales/crackles, jugular venous distension, renal hypoperfusion with no other apparent cause, or radiologic evidence of worsening heart failure. And was also defined by a new therapy specifically for the treatment of worsening or persistent decompensated heart failure.
  
  
• Number of Days Alive and Outside the Hospital [ Time Frame: Randomization to Day 30 ] [ Designated as safety issue: Yes ]
  
• Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality [ Time Frame: Randomization to Day 30 ] [ Designated as safety issue: Yes ]
  

• All-Cause Mortality Through Day 30 [ Time Frame: Randomization to Day 30 ] [ Designated as safety issue: Yes ]
  All deaths were adjudicated by an independent Clinical Events Committee.
  
  
• All-Cause Mortality Through Day 180 [ Time Frame: Randomization to Day 180 ] [ Designated as safety issue: Yes ]
  All deaths were adjudicated by an independent Clinical Events Committee.
  
  
• Cardiovascular Mortality Through Day 30 [ Time Frame: Randomization to Day 30 ] [ Designated as safety issue: Yes ]
  All deaths were adjudicated by an independent Clinical Events Committee (CEC) and the cardiovascular deaths were classified by the CEC based on the primary causes.
  
  
• Number of Patients With Renal Impairment [ Time Frame: Study drug initiation to Day 30 ] [ Designated as safety issue: Yes ]
  Renal impairment was defined as a greater than 25% decrease from baseline in the Modification of Diet in Renal Disease calculated glomerular filtration rate.
  
  

Acute Decompensated Heart Failure (ADHF) is the inability of the heart to pump efficiently, which can result in symptoms like shortness of breath at rest or with minimal activity. ADHF is a condition in which the heart cannot perform the necessary circulation of blood through the body. This is a randomized (study medication is assigned by chance), double-blind (neither the patient or the doctor knows whether the patient is assigned to receive study drug or placebo [does not contain study drug]), placebo-controlled, parallel group, multicenter study of the effectiveness of nesiritide administered continuously through a vein for a minimum of 24 hours up to a maximum of 7 days. The study hypothesis is that nesiritide given in addition to standard care is superior to placebo given in addition to standard care as measured by relief of breathing difficulties (by patient evaluation utilizing a breathlessness scale) at 6 hours or 24 hours after nesiritide administration, and reduction in rehospitalization due to heart failure and death from study drug administration through Day 30. The study drug (nesiritide) or placebo dose being studied is 0.010 mcg/kg/min with or without a 2 mcg/kg initial bolus (one time injection) of nesiritide. Patient safety will be monitored throughout the study through physical exams, vital signs (heart rate, blood pressure, respiratory rate, and temperature), blood tests, and side effects. The patients assigned to the nesiritide group will receive a continuous intravenous (into a vein) infusion at 0.010 mcg/kg/min of nesiritide with or without a 2 mcg/kg bolus (one time injection). The patients assigned to the placebo group will receive matching placebo bolus and infusion. The bolus is given over one minute and the continuous infusion is given for at least 24 hours and up to 7 days.