Nesiritide in Resistant Hypertension

What Was Tested

The trial (phase 1, phase 2) is built around BNP (Nesiritide).

It had two arms (groups): Nesiritide (BNP) (other) and Placebo (placebo comparator).

Subjects will receive SQ placebo bid for seven consecutive days.

The registry classes the interventions as drug.

More on the Plan

Hypertension remains a global burden in cardiovascular disease leading to stroke, myocardial infarction, and heart failure.

The broad objective of proposal is to advance the biology and therapeutics of the natriuretic peptides (NPs) with a special focus on the cardiac peptide BNP in human hypertension.

Who Took Part

12 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: A second line agent such as sympatholytic (e.g. beta-blockade, central agent such as clonidine) or angiotensin converting enzyme inhibitor (ACEi) / angiotensin receptor blocker (ARB) or calcium channel blocker (CCB). Third line agent including one of the above and/or direct vasodilator, such as hydralazine or minoxidil.

The full record lists 3 inclusion and 18 exclusion criteria; among the exclusions: congestive heart failure (any new york heart association (nyha) class); known renal artery stenosis; myocardial infarction within 3 months of screening.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got BNP (Nesiritide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received BNP (Nesiritide).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-04 with completion listed for 2014-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in Systolic Blood Pressure (BP) (time frame: baseline, treatment day 1, treatment day 2).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of BNP (Nesiritide) in 12 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.