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

NCT00119691 | Completed Phase 2

• 1 other identifier: 2003-P00235
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congestive Heart Failure; Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• Renal function

  within 7 days after randomization

Secondary Outcomes (5)

• Weight loss

  Within 7 days from randomization

• Days to optimal volume status

  From randomization till day 7 or sooner

• Concomitant diuretic use

  Within 7 days from randomization

• Global symptom assessment

  24 hrs and 3 days after randomization

• Length of stay

  From admission to discharge or day 7

Study Arms (2)

Nesiritide + standard of care

EXPERIMENTAL

Nesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved.

Drug: Nesiritide

Standard of care

ACTIVE COMPARATOR

Standard of care until adequate diuresis achieved

Drug: Nesiritide

Interventions

Nesiritide DRUG

Nesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved.

Also known as: Natrecor

Nesiritide + standard of care; Standard of care

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Scios, Inc.: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency

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

• Anju Nohria, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician/Assistant Professor

Study Record Dates

• First Submitted: July 7, 2005
• First Posted: July 14, 2005
• Study Start: April 1, 2003
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

US (1)