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Use of Nesiritide (BNP) in Kidney Function in Patients With Congestive Heart Failure (CHF) and Kidney Failure
Plain-language guide to NCT00348556: phase 1, phase 2 interventional trial of BNP (Nesiritide), 4 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00348556
- Phase
- phase 1, phase 2
- Status
- terminated early
- Start
- 2005-12
- Completion (planned or actual)
- 2010-03
- Participants
- 4 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Cardiorenal Syndrome
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1, phase 2) is built around BNP (Nesiritide).
It had 1 arm (groups): Nesiritide (experimental).
The registry classes the interventions as drug.
Who Took Part
4 actual participants took part.
It was open to people of any sex aged from 18 years up to 90 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age 18 years and older. Clinical diagnosis of class III-IV CHF requiring hospitalization. Current acute CHF decompensation. Systolic BP \> 90 mmHg. Stable cardiac rhythm.
The full record lists 8 inclusion and 19 exclusion criteria; among the exclusions: patients needing emergency coronary revascularization or those who may have rapidly changing cardiac function (i.e., patients with acute myocardial infarction or shock); peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period; systolic blood pressure \< 90 mmhg or cardiogenic shock.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when BNP (Nesiritide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2005-12 with completion listed for 2010-03.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in Glomerular Filtration Rate (GFR) at 24 Hours (time frame: baseline, 24 hours after start of infusion).
It also tracked 1 secondary outcome, for example Change in Urinary Sodium Excretion at 24 Hours.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2 trial of BNP (Nesiritide) in 4 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); results are posted on the registry, and this page does not restate them.
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.