Acute Effects of rhBNP in Patients With PH Associated With Acute Exacerbation of Chronic Pulmonary Disease

What Was Tested

In this phase 4 trial, researchers set out to test BNP (Nesiritide).

To evaluate the acute effect of recombinant human brain natriuretic peptide(rhBNP) on pulmonary hypertension of acute exacerbations of chronic pulmonary disease. rhBNP was administered as a continuous infusion for 24 hours , pulmonary artery pressure and other hemodynamic parameters were monitored by Swan- Ganz catheter.

It had two arms (groups): rhBNP (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Pulmonary hypertension (PH) is a descriptive name for abnormally elevated pressures in the pulmonary vasculature, which seriously affects the quality of life and survival of patients.

Thus, the study was designed to administer rhBNP as a continuous infusion for 24 hours on pulmonary hypertension of acute exacerbations of chronic pulmonary disease monitoring by Swan- Ganz catheter.

Who Took Part

The registry lists 9 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: Age\>18 years old, male or female;. In acute exacerbation period and with a history of chronic respiratory diseases;. Grade II or WHO grade of heart function;. Signed informed consent.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: acute or severe chronic left heart failure;; severe respiratory failure during receipt of non-invasive or invasive ventilator therapy;; a high risk of hypotension (systolic pressure \<100 mmhg or 110 mmhg with the use of intravenous nitroglycerin);.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

The participants were allocated by chance, so the BNP (Nesiritide) group and the comparison group should start out alike.

Each person switched between BNP (Nesiritide) and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: participant and outcomes assessor.

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

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): pulmonary artery systolic pressure (PASP) measured by Swan-Ganz catheter (time frame: baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours). pulmonary artery diastolic pressure(PADP) measured by Swan-Ganz catheter (time frame: baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours). mean pulmonary artery pressure(mPAP) measured by Swan-Ganz catheter (time frame: baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours).

It also tracked 12 secondary outcomes, for example heat rate (HR), respiratory rate(RR), blood pressure(BP), blood oxygen saturation(SPO2), Brog classification and Brain Natriuretic Peptide(BNP) in blood.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of BNP (Nesiritide) in 9 people.

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

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.