Status:
COMPLETED
Evaluation of Combined Action Between Natrecor and Furosemide on Kidney and Neurohormone Responses in Chronic Heart Failure: A Phase-IV study704.351 / DSS
Lead Sponsor:
Scios, Inc.
Conditions:
Congestive Heart Failure
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a randomized, open-label, three-way crossover design study with 3 treatment groups:TREATMENT A: Furosemide;TREATMENT B: Nesiritide administered IV bolus, followed by an infusion for 6 hours;TR...
Detailed Description
Nesiritide is the recombinant form of human B-type natriuretic peptide (hBNP). The drug is indicated for the IV treatment of patients with acutely decompensated congestive heart failure who have short...
Eligibility Criteria
Inclusion
- Chronic symptomatic NYHA Class II or III CHF for at least 90 days before the study
- Left ventricular systolic dysfunction as evidenced by left ventricular ejection fraction \< 40%, measured using contrast or radionuclide ventriculography or by echocardiography, within 180 days of the study start
- Serum potassium \> 3.5 mEq/L.
- Chronic oral daily requirement of 80-240 mg of furosemide for at least 7 days before the study start
- Receiving a stable medical regimen for CHF for at least 60 days before the study start, including angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARBs), and/or beta-blockers.
Exclusion
- Clinical instability such that withholding diuretic therapy would be unsafe
- Significant renal impairment (e.g., creatinine clearance \< 45 mL/min by the Cockcroft-Gault formula), or changing renal function during the 7 days before study start, or intrinsic renal disease
- Systolic blood pressure (SBP) consistently \< 90 mm Hg
- Myocardial infarction within 90 days of study start, unstable angina within 14 days of study start, or any clinical evidence of active myocardial ischemia
- Percutaneous coronary intervention or cardiac surgery within 90 days of study start
- Restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, other conditions in which cardiac output was dependent on venous return, or for subjects expected to have low filling pressures
- Prior cardiac or renal allografts
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00652652
Start Date
March 1 2003
End Date
January 1 2004
Last Update
May 19 2011
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