A Study of the Safety and Efficacy of Follow-up Serial Infusions of Natrecor(Nesiritide) for the Management of Patients With Heart Failure

NCT00091520 | Completed Phase 2

• 1 other identifier: CR003355
• Study Type: interventional
• Target: 920
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Nesiritide administered as serial infusions to heart failure (HF) patients in the outpatient setting.

Conditions

Heart Failure, Congestive

Keywords

Congestive heart failure; Nesiritide

Outcome Measures

Primary Outcomes (1)

• Time to all-cause death or first occurrence of hospitalization for cardiovascular and/or renal causes from the day of randomization through week 12.

Secondary Outcomes (1)

• Number of cardiovascular and/or renal hospital admissions adjusted for duration of observation period through the end of week 12. Days alive and out of the hospital from the day of randomization through the end of week 12.

Interventions

Nesiritide DRUG

Eligibility Criteria

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

You may qualify if:

• Had at least two qualifying hospitalizations or hospitalization equivalents in the past year, with the most recent hospitalization or hospitalization equivalent within the past 60 days, but who has been out of the hospital at least 5 days (the day of discharge is day 0)
• Have documentation indicating that the patient was consistently New York Heart Association (NYHA) Class III or IV during the 60 days before randomization
• Have a Left Ventricular Ejection Fraction less than 40% (measured within 24 weeks before randomization)
• Are (1)NYHA Class IV or (2)NYHA Class III with highest calculated CrCl, 60mL/min within the previous 30 days
• Are receiving optimal treatment with long-term oral medications (e.g., diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), and beta blockers, unless these are documented to be contraindicated or not tolerated)
• Agree to come to the clinic up to 2 times per week (according to randomization) for 16 weeks of study drug infusions and to participate in all required follow-up assessments through week 24. In addition, agree to be contacted monthly after week 24 for follow-up, until the entire study has been completed

You may not qualify if:

• Have systolic blood pressure consistently \<90mm Hg
• Are unable or unwilling to discontinue intermittent or continuous infusions of dopamine, dobutamine, milrinone, nitroglycerin, or open-label Natrecor beginning at the time of the screening visit
• Have required recent outpatient IV vasoactive (milrinone, dobutamine, dopamine, nitroglycerin, or open-label Natrecor) therapy as defined as \>2 outpatient (excluding emergency room or inpatient) infusions in the last 30 days without a subsequent hospitalization
• Had, or during the course of the study are anticipated to have, any organ transplantation (heart, liver, lung, kidney, or bone marrow)
• Had a biventricular pacemaker placed within the 45 days before randomization or a single or dual chamber pacemaker or an automatic implantable cardiac defibrillator placed within the 15 days before randomization
• Have cardiogenic shock, volume depletion, or any other clinical condition at the time of randomization that would contraindicate the administration of Natrecor
• Are currently receiving chronic dialysis or have the expectation that dialysis will be required during the next 12 months.

Sponsors & Collaborators

• Scios, Inc.: lead

Related Publications (1)

• Yancy CW, Krum H, Massie BM, Silver MA, Stevenson LW, Cheng M, Kim SS, Evans R; FUSION II Investigators. Safety and efficacy of outpatient nesiritide in patients with advanced heart failure: results of the Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial. Circ Heart Fail. 2008 May;1(1):9-16. doi: 10.1161/CIRCHEARTFAILURE.108.767483.

  PMID: 19808265 DERIVED

Related Links

• Follow-up Serial Infusions of Natrecor(Nesiritide) in the Management of Patients With Heart Failure-FUSION II

MeSH Terms

Conditions

Heart Failure

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular 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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2004
• First Posted: October 1, 2004
• Study Start: April 1, 2004
• Study Completion: December 1, 2006
• Last Updated: May 20, 2011

Record last verified: 2010-03