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NCT00709163 · ClinicalTrials.gov registry record · NA
Nesiritide - Dilated Cardiomyopathy
A NA study of Dilated Cardiomyopathy, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00709163 is a NA study of Dilated Cardiomyopathy that has completed, run by University of California, Los Angeles. The registered enrollment target is 20 participants, below the 260-participant average among 6 other Dilated Cardiomyopathy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00709163, a NA study of Dilated Cardiomyopathy, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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 th
Conditions Studied
Interventions
- DRUG Nesiritide
- DRUG 5% Dextrose
Study Locations (1)
California
- Mattel Children's Hospital at UCLA - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2003-12 |
| Est. Completion | 2005-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00709163
The ClinicalTrials.gov registry entry for NCT00709163 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 260-participant average among 6 other Dilated Cardiomyopathy trials with a reported enrollment target (92% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dilated Cardiomyopathy appearing as the primary indexed condition, and to 2 interventions - of which Nesiritide is the first listed.
NCT00709163 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00709163 about?
NCT00709163 is a clinical study titled "Nesiritide - Dilated Cardiomyopathy". 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 (P...
What is the current status of trial NCT00709163?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2003-12. Estimated completion is 2005-11.
What conditions does trial NCT00709163 study?
This clinical trial studies the following conditions: Dilated Cardiomyopathy.
What interventions are being tested in trial NCT00709163?
The interventions under investigation include: Nesiritide (DRUG), 5% Dextrose (DRUG).
Who is sponsoring clinical trial NCT00709163?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00709163 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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