Nesiritide in Hypertension

What Was Tested

This registered phase 1, phase 2 trial tested BNP (Nesiritide).

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

It had two arms (groups): Subcutaneous BNP (active comparator) and Subcutaneous placebo (placebo comparator).

Patients will receive subcutaneously administered placebo twice daily for two days for determination of the effect of BNP.

The registry classes the interventions as drug.

Who Took Part

The registry lists 15 planned participants were the target.

It was open to people of any sex aged from 18 years up to 79 years.

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

Examples of who could join: Office systolic blood pressure (SBP) ≥ 120 mmHg and treatment with at least one anti-hypertensive medication. Unchanged medication regimen the last two weeks prior to inclusion. Average day-time SBP \> 115 on a 24-h ambulatory BP measurement at screening.

The full record lists 2 inclusion and 27 exclusion criteria; among the exclusions: congestive heart failure (any new york heart association class); known, not appropriately treated, secondary hypertension; myocardial infarction within 3 months of screening.

How the Study Was Run

Design: randomized, parallel-group and single-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.

In this single-blind BNP (Nesiritide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2015-12 with completion listed for 2018-12.

It ran at 3 sites in Norway (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Changes in blood pressure (BP).

It also tracked 3 secondary outcomes, for example Renal function as assessed by estimated glomerular filtration rate (eGFR).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of BNP (Nesiritide) in 15 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the BNP (Nesiritide) compound page, all human trials.