ASCEND-HF Acute Study of Clinical Effectiveness of Nesiritide in Subjects with Decompensated Heart Failure

1
ASCEND-HFAcute Study of Clinical Effectiveness
of Nesiritide in Subjects with Decompensated
Heart Failure

• Duke Heart Failure Research
• Pager 970-0736

2
Purpose

• Double blinded placebo-controlled study to
  evaluate efficacy and safety of Nesiritide
  (Natrecor) in addition to standard care vs.
  placebo with standard care in patients with acute
  decompensated heart failure.
• Double blinded study meaning subjects, MD, and
  research team are unaware of what treatment is
  being received.

3

• Nesiritide (Natrecor) A medication used to
  treat acute decompensted HF. It is a form of
  human BNP that promotes vasodilation,
  natriuresis, and diuresis.

4
Inclusion Criteria

• Dyspnea at rest
• Pulmonary congestion

• Signs/symptoms within 24 hrs of admission

5
Interventions

• USE OF OPEN LABEL NESIRITIDE IS NOT ALLOWED AT
  ANY TIME!!

6

• See Protocol Instructions and follow titration
  directions. This information is kept in
  patients chart box.
• Side effects of Nesiritide (see Adverse Reactions
  List) http//www.clinicalpharmacology-ip.com/Form
  s/Monograph/monograph.aspx?cpnum2134secmonadve

7
Nursing Roles

• Nesiritide infusion of 0.010 mcg/kg/min with or
  without 2mcg/kg bolus vs. placebo
• Change bag every 24 hrs.
• Monitor VS q 5min. x4, q 30min. x2, and then q
  hr. x4

8
Nursing Roles

• Ask subjects to fill out questionnaires and
  Visual Analog Scales (VAS) at 6 and 24 hrs
• QUESTIONNAIRES and VAS INCLUDE
• Dyspnea self assessments
• Health status/well-being, mobility, self-care,
  pain, depression, activities
• Found in patients chart box.

9
Outcomes

• Why is this study being done?
• Does Nesiritide decrease re-hospitalization or
  death in 30 days?
• Does Nesiritide decrease symptoms of dyspnea at 6
  and 24 hrs after drug initiated?

10
Outcomes

• Measure overall well-being at 6 and 24 hrs
• Measure of days alive and of days outside
  hospital from randomization to day 30
• Measure cardiovascular re-hospitalization and
  mortality from randomization to day 30