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B-type Natriuretic Peptide (BNP) in Human Hypertension
Plain-language guide to NCT00953472: phase 1 non-randomized trial of BNP (Nesiritide), 8 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00953472
- Phase
- phase 1
- Status
- terminated early
- Start
- 2009-02
- Completion (planned or actual)
- 2011-04
- Participants
- 8 (estimated)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Hypertension Stage 1
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested BNP (Nesiritide).
The investigators working hypothesis is that human hypertension is in part due to a derangement in the endocrine function of the heart - a primary or secondary mechanism - resulting in a relative deficiency of the natriuretic peptides (NP).
The registry classes the interventions as drug and other.
More on the Plan
Ongoing investigations by their laboratory group and others have established that the heart is an endocrine organ as well as a pump.
The heart synthesizes and secretes two peptide hormones - atrial natriuretic peptide (ANP) and B-type natriuretic peptide (BNP) - that are endogenous ligands for a particulate guanylyl cyclase receptor (NPR-A).
Hypertension remains a global burden in cardiovascular disease leading to stroke, myocardial infarction and heart failure.
Who Took Part
Enrollment: 8 planned participants were the target.
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. Subjects with stage 1 hypertension (SBP: 140-159 mm Hg or DBP 90-99 mm Hg) If on therapy, it must be stable for at least 1 month.
The full record lists 2 inclusion and 16 exclusion criteria; among the exclusions: congestive heart failure (any nyha class); myocardial infarction within 3 months of screening; unstable angina within 14 days of screening, or any evidence of myocardial ischemia.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
Nothing was hidden in this open-label BNP (Nesiritide) study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2009-02 with completion listed for 2011-04.
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 1, non-randomized trial of BNP (Nesiritide) in 8 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); 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.