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ASCEND-HF
Acute Study of Clinical Effectiveness of Nesiritide
in Subjects with Decompensated Heart Failure
Duke Heart Failure Research
Pager: 970-0736
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.
Nesiritide (Natrecor) – A medication
used to treat acute decompensted
HF. It is a form of human BNP that
promotes vasodilation, natriuresis,
and diuresis.
Inclusion Criteria
• Dyspnea at rest
• Pulmonary
congestion
• Signs/symptoms
within 24 hrs of
admission
Interventions
Randomized to
1 of 2
groups
Nesiritide plus
standard of care
Placebo plus
standard of care
USE OF OPEN LABEL NESIRITIDE IS NOT ALLOWED AT ANY TIME!!
• See “Protocol Instructions” and follow titration
directions. This information is kept in
patient’s chart box.
• Side effects of Nesiritide (see Adverse Reactions
List): http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpn
um=2134&sec=monadve
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
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 patient’s chart box.
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?
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