Phase 3 N=7,141 Randomized Quadruple-blind Treatment

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

Heart Decompensation

Bottom Line

View on ClinicalTrials.gov: NCT00475852 ↗

Enrolled (actual)

7,141

Serious AEs

0.1%

Results posted

May 2012

Primary outcome: Primary: Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality — 321; 345 Participants — p=0.313

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Nesiritide (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Scios, Inc.
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality	321; 345	0.313
PRIMARY Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug	513; 460; 1007; 989; 1119; 1174	0.030 sig
PRIMARY Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug	1025; 935; 1274; 1313; 716; 751	0.007 sig
SECONDARY Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug	449; 418; 962; 965; 1154; 1186	0.318
SECONDARY Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug	913; 843; 1297; 1311; 761; 798	0.018 sig
SECONDARY Composite of Persistent or Worsening Heart Failure and All-Cause Mortality	147; 165	0.295
SECONDARY Number of Days Alive and Outside the Hospital	20.9; 20.7	0.160
SECONDARY Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality	372; 402	0.238

Summary

The purpose of this study is to find out if nesiritide (a human B-type natriuretic peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart failure, helps to improve breathing difficulties, reduce heart failure readmissions to hospitals, and helps patients live longer.

Eligibility Criteria

Inclusion Criteria

Hospitalized for the management of acute decompensated heart failure (ADHF) or diagnosed with ADHF within 48 hours after being hospitalized for another reason; Diagnosis of ADHF is defined as dyspnea (difficulty breathing) at rest or dyspnea with minimal activity.

Exclusion Criteria

At high risk for hypotension (low blood pressure); Acute coronary syndrome as primary diagnosis; History of cardiac valvular stenosis, restrictive cardiomyopathy, hypertrophic cardiomyopathy, or pericardial tamponade; Previous enrollment in a nesiritide study; Persistent, uncontrolled hypertension (SBP [systolic blood pressure] >180 mmHg).

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Data sourced from ClinicalTrials.gov (NCT00475852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.