Nesiritide – Dilated Cardiomyopathy

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Brief Title

Nesiritide - Dilated Cardiomyopathy

Official Title

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

Brief Summary

      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:

        1. 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.

        2. To assess the efficacy of Nesiritide in decreasing pulmonary edema and increasing
           cardiac index in the above mentioned population.

        3. To assess the safety of both bolus administration and continuous infusion of Nesiritide
           in children with dilated cardiomyopathy.

        4. To assess the pharmacokinetics of Nesiritide in this population.
    



Study Type

Interventional




Condition

Dilated Cardiomyopathy

Intervention

Nesiritide

Study Arms / Comparison Groups

 1
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

December 2003

Completion Date

November 2005

Primary Completion Date

November 2005

Eligibility Criteria

        Inclusion Criteria:

          1. Diagnosis of dilated cardiomyopathy

          2. Less than 21 years of age

          3. Patient admitted to the intensive care unit

          4. Patient requiring placement of a Swan-Ganz catheter

          5. Patient's hemodynamics or clinical condition requires the use of a Swan-Ganz catheter
             for 26 hours following the cardiac catheterization.

          6. Patient has signed an IRB approved consent form.

        Exclusion Criteria:

          1. Severe hemodynamic instability including patients requiring ECMO

          2. Cardiac catheterization not indicated
      

Gender

All

Ages

N/A - 21 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00709163

Organization ID

A026



Study Sponsor

University of California, Los Angeles

Collaborators

 Scios, Inc.

Study Sponsor

, , 


Verification Date

June 2008