rhBNP in Type 3 Pulmonary Hypertension

What Was Tested

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

Pulmonary hypertension is a common clinical syndrome, which seriously affects the quality of life and survival of patients.

Pulmonary hypertension can be divided into five types, among which pulmonary hypertension caused by chronic pulmonary diseases and/or hypoxia is called Group 3 pulmonary hypertension, which is the most important factor of pulmonary heart disease.

It had two arms (groups): recombinant human brain natriuretic peptide (active comparator) and placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The study was divided into three stages, including screening period (3 days), treatment period (72 hours) and follow-up period (10 ± 2 days and 30 ± 5 days).

After the subjects signed the informed consent form, they completed all screening tests.

The qualified subjects immediately started the basic treatment of Group 3 pulmonary hypertension.

Three days later, they underwent right heart echocardiography and Swan-Ganz catheterization.

Who Took Part

The registry lists 72 planned participants were the target.

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: At rest, the systolic pressure of pulmonary artery measured by right heart Doppler ultrasound was ≥ 50mmHg;. At rest, the mean pulmonary artery pressure (mPAP) measured by Swan Ganz catheter was ≥ 25mmHg with PVR ≥ 3WU and PAWP \< 15mmHg;. Male or female, age ≥ 18 years old, weight ≥ 30kg \~ ≤ 150kg;. WHO fc ≥ II.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: any other types of pulmonary hypertension;; other active respiratory diseases (such as active pulmonary tuberculosis, pulmonary fibrosis, etc.);; patients requiring invasive mechanical ventilation;.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

The BNP (Nesiritide) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on BNP (Nesiritide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2023-04-15 with completion listed for 2023-12-31.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean pulmonary artery pressure (mPAP) (time frame: 72 hours).

It also tracked 7 secondary outcomes, for example Systolic pressure of pulmonary artery（PASP）, 6MWD, WHO fc, Oxygen partial pressure, dyspnea and NT-proBNP.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of BNP (Nesiritide) in 72 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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