Study of Low Dose Nesiritide With or Without Sildenafil in Congestive Heart Failure Patients With Renal Dysfunction

What Was Tested

In this phase 1 trial, researchers set out to test BNP (Nesiritide).

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

The registry classes the interventions as drug.

More on the Plan

Renal dysfunction is a common comorbidity, as well as a common and progressive complication, of heart failure (HF).

Recent studies have established the prognostic importance of renal dysfunction in patients with chronic HF.

In an ongoing prospective study, the researchers are assessing the neurohumoral and renal hemodynamic profile of hospitalized patients with ADHF who do or do not develop the CRS.

Who Took Part

1 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: Stable (NYHA) class II and III symptoms as defined by:. No change in NYHA symptoms over the past 3 months;. No episode of decompensated CHF over the past 3 months.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: nitrates or alpha blockers; peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period; hospitalization for decompensated chf during the past 3 months.

How the Study Was Run

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

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

In the crossover set-up each of the participants took both BNP (Nesiritide) and the comparison in turn, acting as their own control.

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, care provider and investigator.

It started in 2009-02 with completion listed for 2010-08.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

It also tracked 1 secondary outcome, for example We also want to characterize both plasma and urinary humoral profile in these patients.

What This Means in Plain Language

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