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

May 19, 2011 updated by: Scios, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Heart Failure (HF) is the inability of the heart to pump efficiently and the heart cannot perform the necessary circulation of blood through the body. This can result in symptoms like shortness of breath at rest or with minimal activity. Advanced heart failure is one of the leading causes of hospitalization and deaths in the United States. This is a prospective randomized, double-blind, placebo-controlled parallel group, multicenter study of the effectiveness of Nesiritide administered as serial infusions in the outpatient setting. Patients enrolled in this study will receive nesiritide or placebo for up to 12 weeks. Patients will then be followed for an additional 12 weeks. During the the first 17 weeks of the study patients will have multiple laboratory tests, have their vital signs (blood pressure and heart rate) assessed, and complete quality of life questionnaires. During the last few weeks of the study patients will be contacted to inquire how they are doing. The study hypothesis is that compared to placebo plus standard care, Nesiritide plus standard will reduce time to death or first occurrence of hospitalization due to heart or kidney problems. Safety will be assessed through the collection of adverse events, clinical laboratory tests and vital signs at various time points throughout the study. The patients assigned to the nesiritide group will receive a single 2.0mcg/kg bolus (one time injection) followed by serial IV infusions (4 to 6 hours) at a standard flow rate of 0.010 mcg/kg/min once or twice per week for 12 weeks. The patients assigned to the placebo group will receive matching placebo.

Study Type

Interventional

Enrollment (Actual)

920

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scios, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 9, 2004

First Submitted That Met QC Criteria

September 30, 2004

First Posted (Estimate)

October 1, 2004

Study Record Updates

Last Update Posted (Estimate)

May 20, 2011

Last Update Submitted That Met QC Criteria

May 19, 2011

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003355

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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