Use of Nesiritide in the Management of Acute Diastolic Heart Failure

What Was Tested

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

It had 1 arm (groups): 1 (experimental).

Nesiritide.

The registry classes the interventions as drug.

More on the Plan

Patients with diastolic heart failure often have high pressure in their heart and lungs and many symptoms such as shortness of breath, low energy, fluid retention, and fatigue.

The drug nesiritide was designed to help treat heart failure.

Before treatment starts, you will be asked questions about your medical history and about any medications you are currently taking.

You will have a complete physical exam.

Who Took Part

Enrollment: 9 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Age 18 to 85 years old. Admitted with acute heart failure determined by: symptoms of fatigue; shortness of breath; edema; physical evidence of volume overload; and/or pulmonary edema by CXR. NYHA class III or IV on admission. Baseline systolic blood pressure \> 90 mm Hg. Baseline BNP level \> 100 pg/ml.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: active infection/sepsis as defined by fever \> 101.5 f, currently on iv antibiotics; severe thrombocytopenia (as defined by platelets less than 20,000) or inr \> 1.6; hypersensitivity to nesiritide or any of its components.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Everyone knew when BNP (Nesiritide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2004-05-17 with completion listed for 2006-04-24.

Its stated primary purpose is treatment.

What This Means in Plain Language

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