ASCEND-HF Acute Study of Clinical Effectiveness of Nesiritide in Subjects with Decompensated Heart Failure Duke Heart Failure Research Pager:

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): ip.com/Forms/Monograph/monograph.aspx?cpn um=2134&sec=monadve ip.com/Forms/Monograph/monograph.aspx?cpn um=2134&sec=monadve

Nursing Roles Nesiritide infusion of 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