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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119691
• Other study ID #: 2003-P00235
• Status: Completed
• Phase: Phase 2
• First received: July 7, 2005
• Last updated: September 11, 2013
• Start date: April 2003
• Est. completion date: November 2005

Study information

• Verified date: September 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Renal Insufficiency

Intervention

Drug:
• Nesiritide
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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Scios, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function		within 7 days after randomization	Yes
Secondary	Weight loss		Within 7 days from randomization	No
Secondary	Days to optimal volume status		From randomization till day 7 or sooner	No
Secondary	Concomitant diuretic use		Within 7 days from randomization	No
Secondary	Global symptom assessment		24 hrs and 3 days after randomization	No
Secondary	Length of stay		From admission to discharge or day 7	No