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A Study of Two Doses of Intravenous NATRECOR hBNP (Nesiritide) in Patients With Worsening Congestive Heart Failure Who Have Difficulty Breathing at Rest
Plain-language guide to NCT00288730: phase 3 randomized trial of BNP (Nesiritide), 127 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00288730
- Phase
- phase 3
- Status
- completed
- Start
- 1996-10
- Completion (planned or actual)
- 1997-08
- Participants
- 127 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Heart Failure, Congestive; Heart Decompensation
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around BNP (Nesiritide).
It had 1 arm (groups): 001 (experimental).
Nesiritide.
The registry classes the interventions as drug.
More on the Plan
Human studies reported by SJ Holmes et al, 1993, AM Richards et al, 1993 and M.
Plasma hBNP levels are elevated in CHF and hBNP may be one of the body's natural compensatory mechanisms to augment cardiac functions in a failing heart.
Who Took Part
Enrollment: 127 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: History of chronic congestive heart failure (CHF). Symptomatic, decompensated CHF for which intravenous therapy is deemed appropriate for the hospitalized patient.
The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: had a myocardial infarction within the previous 48 hours or unstable angina; clinical status so unstable that the subject can not tolerate placement of a swan-ganz catheter.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
Because people in this BNP (Nesiritide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The BNP (Nesiritide) group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received BNP (Nesiritide).
It started in 1996-10 with completion listed for 1997-08.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of BNP (Nesiritide) in 127 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.