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Impact of Nesiritide Infusion for Decompensated Heart Failure in the Emergency Department
Plain-language guide to NCT00559338: phase 4 randomized trial of BNP (Nesiritide), 104 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00559338
- Phase
- phase 4
- Status
- completed
- Start
- 2003-12
- Completion (planned or actual)
- 2005-04
- Participants
- 104 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Heart Failure, Congestive; Cardiomyopathy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around BNP (Nesiritide).
It had two arms (groups): 1 (active comparator) and 2 (placebo comparator).
The registry classes the interventions as drug.
More on the Plan
The researchers also acknowledged that the safety of nesiritide in their patient population had not been well established.
Who Took Part
Enrollment: 104 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients who were adults greater than 18 years of age. A history of established heart failure. Dyspnea at rest or with minimal exertion and with a respiratory rate greater than 24 breaths per minute. Evidence of volume overload based on physical exam findings or chest radiograph, and a brain natriuretic peptide (BNP) level greater than 100 pg/ml.
The full record lists 4 inclusion and 17 exclusion criteria; among the exclusions: systolic blood pressure of less than 90 mm hg; frank or impending cardiogenic shock; cardiopulmonary arrest.
How the Study Was Run
Design: randomized, parallel-group and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got BNP (Nesiritide) and who got the comparison, which limits bias.
The BNP (Nesiritide) group and the comparison group ran side by side rather than switching.
As a double-blind BNP (Nesiritide) study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2003-12 with completion listed for 2005-04.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of BNP (Nesiritide) in 104 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the BNP (Nesiritide) compound page, all human trials.
Our Notes on the Compound
BNP (Nesiritide): B-type natriuretic peptide, a 32-amino-acid heart hormone; nesiritide (Natrecor) is a recombinant form used in acute heart failure.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.