A Safety Study Comparing Natrecor (Nesiritide) Versus Dobutamine Therapy for Worsening Congestive Heart Failure

NCT00270400 | Completed Phase 3

• 1 other identifier: CR005200
• Study Type: interventional
• Target: 255
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the effects on heart rate and ventricular arrhythmias (irregular heart beats) of two doses of Natrecor® (a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) versus dobutamine, during the first 24 hours of treatment of decompensated congestive heart failure (CHF).

Conditions

Heart Failure, Congestive

Keywords

Heart Failure; Renal Dysfunction; Cardiomyopathy; Heart Decompensation; Dyspnea Paroxsymal.

Outcome Measures

Primary Outcomes (1)

• Average heart rate; average hourly premature ventricular beats; average hourly repetitive beats, all expressed as a change from baseline

Secondary Outcomes (1)

• Incidence of tachycardia through 24 hours; Incidence of tachycardia, pain, and injection site reaction through 14 days .

Study Arms (1)

001

EXPERIMENTAL

nesiritide

Drug: nesiritide

Interventions

nesiritide DRUG

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of NYHA (New York Heart Association) Class III or IV congestive heart failure (CHF)
• Has symptomatic, decompensated CHF for which inpatient therapy with either dobutamine or Natrecor®, administered as a single intravenous vasoactive agent (drugs that influence the tone and caliber of blood vessels) with or without diuretics, is deemed appropriate
• Receiving stable doses of oral antiarrhythmic medications (medications that help regulate irregular heart beats) for at least the 48 hours before starting study drug, or receiving no antiarrhythmic medications.

You may not qualify if:

• Cannot tolerate a 24-Hour Baseline Holter Monitoring Period without intravenous vasoactive medications, and/or cannot tolerate the specified washout period (if applicable) of intravenous vasoactive medications before starting the baseline Holter monitoring
• Has systolic blood pressure consistently \< 85 mm Hg, cardiogenic shock, or other evidence of significant hemodynamic instability requiring the immediate institution of inotropic/pressor support
• Has a clinical condition expected to require therapy with more than one intravenous vasoactive agent or Dopamine during the 24-Hour Treatment Holter Monitoring Period
• Has received treatment with Dopamine or any intravenous vasoactive medication such as Dobutamine, Milrinone, Nitroprusside or intravenous Nitroglycerin for more than 4 hours for the current episode of decompensated CHF or related illness
• Requires an intravenous antiarrhythmic medication during the 48 hours before starting the study

Sponsors & Collaborators

• Scios, Inc.: lead

Related Publications (2)

• Burger AJ, Horton DP, LeJemtel T, Ghali JK, Torre G, Dennish G, Koren M, Dinerman J, Silver M, Cheng ML, Elkayam U; Prospective Randomized Evaluation of Cardiac Ectopy with Dobutamine or Natrecor Therapy. Effect of nesiritide (B-type natriuretic peptide) and dobutamine on ventricular arrhythmias in the treatment of patients with acutely decompensated congestive heart failure: the PRECEDENT study. Am Heart J. 2002 Dec;144(6):1102-8. doi: 10.1067/mhj.2002.125620.

  PMID: 12486437 RESULT

• Nearing BD, Wellenius GA, Mittleman MA, Josephson ME, Burger AJ, Verrier RL. Crescendo in depolarization and repolarization heterogeneity heralds development of ventricular tachycardia in hospitalized patients with decompensated heart failure. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):84-90. doi: 10.1161/CIRCEP.111.965434. Epub 2011 Dec 8.

  PMID: 22157521 DERIVED

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency; Cardiomyopathies

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Scios, Inc. Clinical Trial

  Scios, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Start: August 1, 1998
• Study Completion: February 1, 1999
• Last Updated: June 10, 2011

Record last verified: 2011-06