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.

NCT00270361 | Completed Phase 3

• 2 other identifiers: CR003316NATRECORHFA2001
• Study Type: interventional
• Target: 214
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the safety and tolerability of two doses of nesiritide (a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) when administered serially as a treatment to outpatients with worsening congestive heart failure (decompensated CHF) who are receiving their usual cardiac medications and are at high risk for hospitalization.

Conditions

Heart Failure, Congestive

Keywords

Heart Failure; Renal Dysfunction; Cardiomyopathy; Heart Decompensation; Dyspnea Paroxsymal; Outpatient Therapy.

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of treatment of nesiritide as an adjunct to standard medical therapy

Secondary Outcomes (1)

• In NYHA Class IV patients with renal disease; number of hospitalizations, deaths, adverse cardiovascular events, and, adverse renal events

Study Arms (3)

001

EXPERIMENTAL

nesiritide

Drug: nesiritide

002

EXPERIMENTAL

nesiritide

Drug: nesiritide

003

ACTIVE COMPARATOR

usual long term cardiac medications

Drug: usual long term cardiac medications

Interventions

nesiritide DRUG

001

usual long term cardiac medications DRUG

003

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects having had at least two hospital admissions (or equivalent treatment) for acutely decompensated CHF within the last 12 months, with at least one of these admissions in the past 30 days, and having received treatment with intravenous vasoactive agents (such as intravenous inotropes, NATRECOR®, or nitroglycerin)
• 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.

You may not qualify if:

• 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
• having had a bi-ventricular pacemaker placed within the past 60 days or an automatic implantable cardiac defibrillator placed within the past 30 days
• requiring chronic dialysis or have an expectation that dialysis will be required during the course of the study.

Sponsors & Collaborators

• Scios, Inc.: lead

Related Publications (1)

• Yancy CW, Saltzberg MT, Berkowitz RL, Bertolet B, Vijayaraghavan K, Burnham K, Oren RM, Walker K, Horton DP, Silver MA. Safety and feasibility of using serial infusions of nesiritide for heart failure in an outpatient setting (from the FUSION I trial). Am J Cardiol. 2004 Sep 1;94(5):595-601. doi: 10.1016/j.amjcard.2004.05.022.

  PMID: 15342289 RESULT

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency; Cardiomyopathies

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Scios, Inc. Clinical Trial

  Scios, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Start: December 1, 2001
• Study Completion: January 1, 2003
• Last Updated: July 26, 2011

Record last verified: 2011-07