Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction

This study is currently recruiting participants.

Verified by Brigham and Women's Hospital, February 2005

Sponsors and Collaborators:	Brigham and Women's Hospital Scios, Inc.
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00119691

Purpose

The researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.

Condition	Intervention	Phase
Congestive Heart Failure Renal Insufficiency	Drug: Nesiritide	Phase II

MedlinePlus related topics: Heart Failure

Drug Information available for: Nesiritide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Renal function

Secondary Outcome Measures:

Weight loss
Days to optimal volume status
Concomitant diuretic use
Global symptom assessment
Length of stay

Estimated Enrollment:	64
Study Start Date:	April 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Decompensated heart failure hospitalization with at least 1 symptom and 1 sign of elevated filling pressures
Admission estimated creatinine clearance =< 50 cc/min.

Exclusion Criteria:

Systolic blood pressure < 85 mm Hg
Cardiogenic shock
Volume depletion
Myocardial infarction, unstable angina within last 30 days
Significant valvular stenosis, hypertrophic/restrictive cardiomyopathy, or constrictive pericarditis
Chronic hemodialysis
Anticipated major procedure during hospitalization i.e. left heart catheterization, surgery, or transplantation
Enrolled in another research protocol within last 30 days.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119691

Contacts

Contact: Anju Nohria, MD	617-525-6852	anohria@partners.org
Contact: Kimberly Brooks, RN	617-732-6237	kbrooks@partners.org

Locations

United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kimberly Brooks, RN 617-732-6237 kbrooks@partners.org
Principal Investigator: Anju Nohria, MD

Sponsors and Collaborators

Brigham and Women's Hospital

Scios, Inc.

Investigators

Principal Investigator:

Anju Nohria, MD

Brigham and Women's Hospital

More Information

Study ID Numbers:	2003-P00235
Study First Received:	July 7, 2005
Last Updated:	July 13, 2005
ClinicalTrials.gov Identifier:	NCT00119691
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Natriuretic Peptide, Brain
Heart Failure
Renal Insufficiency

Heart Diseases
Urologic Diseases
Kidney Diseases

Additional relevant MeSH terms:

Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs

Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009