Nesiritide - Dilated Cardiomyopathy - Full Text View

Purpose

Nesiritide is a rapid vasodilator that mimics the action of an endogenous hormone - human B-type natriuretic peptide (BNP). BNP is produced naturally in the ventricles of the heart in response to stretch.

Nesiritide decreases systemic vascular resistance (SVR), pulmonary capillary wedge pressure (PCWP), right atrial pressure (RAP), and mean pulmonary arterial pressure. Nesiritide does not affect the heart rate, but does increase the stroke volume and consequently cardiac output, resulting in a decrease in the symptoms of decompensated heart failure. It is generally well tolerated, with the major negative side effect being hypotension. When compared to standard therapy consisting of dobutamine and nitroglycerin, nesiritide had similar vasodilatory effects, but showed a lower incidence of arrhythmia.

Nesiritide has been approved for IV treatment of patients with acutely decompensated congestive heart failure. Although studies have tested the effectiveness and safety of nesiritide in adult CHF patients, this has not been done in children.

Subjects enrolled in this study will be pediatric (<21 years) patients carrying a diagnosis of dilated cardiomyopathy with decompensated congestive heart failure. The standard of care for these patients is to undergo cardiac catheterization with placement of a Swan-Ganz catheter for hemodynamic monitoring. Subjects will be randomly assigned to receive either Nesiritide or placebo (5% Dextrose). The infusion will then be continued for a total of twenty-four hours. During this one day period, measurements of systemic blood pressure, central venous pressure (right atrial pressure), pulmonary capillary wedge pressure, cardiac output, mixed venous saturation, pulmonary vascular resistance, and systemic vascular resistance will be measured at regularly scheduled intervals. The Swan-Ganz catheter will remain in place for 2 hours after the discontinuation of study drug, and then removed.

The objectives of this study are:

To assess the efficacy of Nesiritide therapy in decreasing the pulmonary capillary wedge pressure, right atrial pressure, and systemic vascular resistance in children with dilated cardiomyopathy.
To assess the efficacy of Nesiritide in decreasing pulmonary edema and increasing cardiac index in the above mentioned population.
To assess the safety of both bolus administration and continuous infusion of Nesiritide in children with dilated cardiomyopathy.
To assess the pharmacokinetics of Nesiritide in this population.

Condition	Intervention
Dilated Cardiomyopathy	Drug: Nesiritide Drug: 5% Dextrose

MedlinePlus related topics:

Cardiomyopathy Heart Failure

Drug Information available for:

Nesiritide Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Nesiritide as an Adjunctive Therapy for Children With Dilated Cardiomyopathy Admitted to the Intensive Care Unit

Further study details as provided by University of California, Los Angeles:

Enrollment:	20
Study Start Date:	December 2003
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Nesiritide The patient will be given an initial bolus of 1mcg/kg and then placed on a continuous infusion of 0.01mcg/kg/min. Three hours after the start of the infusion the patient will be rebolused with 1mcg/kg and increase the continuous infusion to 0.015mcg/kg/min. This will occur again at 6 hours after the start with an increase in the continuous infusion rate to 0.02mcg/kg/min. Patients will continue on the study drug for a total of 24 hours.
2: Placebo Comparator	Drug: 5% Dextrose The patient will be given an initial bolus of 1mcg/kg and then placed on a continuous infusion of 0.01mcg/kg/min. Three hours after the start of the infusion the patient will be rebolused with 1mcg/kg and increase the continuous infusion to 0.015mcg/kg/min. This will occur again at 6 hours after the start with an increase in the continuous infusion rate to 0.02mcg/kg/min. Patients will continue on the study drug for a total of 24 hours.

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of dilated cardiomyopathy
Less than 21 years of age
Patient admitted to the intensive care unit
Patient requiring placement of a Swan-Ganz catheter
Patient's hemodynamics or clinical condition requires the use of a Swan-Ganz catheter for 26 hours following the cardiac catheterization.
Patient has signed an IRB approved consent form.

Exclusion Criteria:

Severe hemodynamic instability including patients requiring ECMO
Cardiac catheterization not indicated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709163

Locations


United States, California
	Mattel Children's Hospital at UCLA
	Los Angeles, California, United States, 90095

Sponsors and Collaborators

University of California, Los Angeles

Scios, Inc.

More Information

Responsible Party:	Department of Pediatrics, University of California Los Angeles ( Juan Alejos, MD - Principal Investigator )
Study ID Numbers:	A026
First Received:	July 1, 2008
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00709163
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

Pediatric

Dilated Cardiomyopathy

Nesiritide

Study placed in the following topic categories:

Natriuretic Peptide, Brain

Heart Diseases

Cardiomyopathy, Dilated

Dilated cardiomyopathy

Cardiomegaly

Cardiomyopathies

Additional relevant MeSH terms:

Natriuretic Agents

Therapeutic Uses

Physiological Effects of Drugs

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 04, 2008

Sponsors and Collaborators:	University of California, Los Angeles Scios, Inc.
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00709163