FUSION I Assesses Safety and Tolerability of Two Doses of NATRECOR (Nesiritide) Administered to Patients With Worsening Congestive (Decompensated) Heart Failure Who Are Concurrently Receiving Their Usual Cardiac Medications and Are at High Risk for Hospitalization.

What Was Tested

In this phase 3 trial, researchers set out to test BNP (Nesiritide).

It had three arms (groups): 001 (experimental), 002 (experimental) and 003 (active comparator).

Nesiritide.

Nesiritide.

Usual long term cardiac medications.

The registry classes the interventions as drug.

More on the Plan

This study is a multicenter, open-label pilot study in which subjects who have received treatment for acutely decompensated CHF during a hospitalization at least twice within the previous 12 months are randomized (1:1:1) to one of three treatment groups.

One treatment group will receive their usual long term cardiac medications, either with or without serial infusions of inotropes (various drugs that affect the strength of contractions of the heart muscle) and without nesiritide therapy.

The hypothesis is that as an adjunct therapy to oral medications, serial IV infusions of nesiritide may produce more rapid and sustained compensation of heart failure in patients with frequent episodes of decompensated heart failure.

Intravenous bolus over 60 seconds and a fixed rate infusion of 4 - 6 hours, at least once per week for 12 weeks.

Who Took Part

Enrollment: 214 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: Able to be enrolled and initiate treatment with study drug within 5 to 30 days of last hospital discharge (or equivalent treatment) of acutely decompensated CHF. Have a baseline NYHA (New York Heart Association) Functional Classification III or IV for at least 2 months prior to randomization. Currently receiving optimal treatment with long term oral medications (e.g., diuretics, ACE inhibitors, and beta blockers, unless beta blockers or ACE inhibitors are documented to be contraindicated or not tolerated). Willing to receive infusions of NATRECOR®, or possibly other medications, at least as frequently as once per week for 12 weeks.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: subjects having systolic blood pressure consistently less than 90 mm hg; having had organ transplantation (heart, liver, lung and kidney) in the past or anticipating organ transplantation during the study; not able or willing to discontinue intermittent or continuous infusions of inotropes if randomized to a natrecor® treatment group.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this BNP (Nesiritide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label BNP (Nesiritide) study: the participants and staff both knew the treatment.

It started in 2001-12 with completion listed for 2003-01.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Safety and tolerability of treatment of nesiritide as an adjunct to standard medical therapy.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of BNP (Nesiritide) in 214 people.

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.