ASCEND-HFAcute 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.
Dyspnea at rest Pulmonary congestion Signs/symptoms within 24 hrs of admission Inclusion Criteria
Interventions • 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.clinicalpharmacology-ip.com/Forms/Monograph/monograph.aspx?cpnum=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