Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of two doses of intravenous NATRECOR® hBNP (a recombinant form of the natural human peptide normally secreted by the heart) versus placebo in the treatment of patients with symptomatic, decompressed congestive heart failure (CHF).


Clinical Trial Description

Human studies reported by SJ Holmes et al, 1993, AM Richards et al, 1993 and M. Yoshimara et al, 1991 show that administration of externally produced hBNP produces vasodilation; antagonism of the hormone system that helps regulate long term blood pressure and blood volume in the body; and an increase in urine output containing large amounts of salt. These studies suggest hBNP may be a potent agent for the treatment of acute congestive heart failure (CHF) with a unique combination of desirable effects on the flow of blood throughout the body; the hormones secreted by the nervous system; and support of copious salt outputs by the renal system not provided by currently available therapies. Plasma hBNP levels are elevated in CHF and hBNP may be one of the body's natural compensatory mechanisms to augment cardiac functions in a failing heart. NATRECOR® hBNP is Scios' proprietary form of hBNP and it is identical to the amino acid sequence in the naturally occurring hormone. This is a randomized, double-blinded, placebo-controlled, multicenter study to determine the efficacy of two distinct doses of NATRECOR® hBNP in patients with symptomatic, decompensated congestive heart failure to decrease pulmonary capillary wedge pressure, as measured by a blinded comparison to placebo after 6 hours of treatment. Patients are randomized to receive either a placebo or one of two doses (0.015 or 0.03 µg/kg/min) of NATRECOR® hBNP. The study hypothesis is that NATRECOR ® hBNP is well tolerated and an effective agent for the short-term management of hospitalized patients with symptomatic, decompensated CHF. Patients are randomized to receive either a placebo or one of two doses (0.015 or 0.03 µg/kg/min) of NATRECOR® hBNP. Doses are administered one time only, an intravenous loading bolus, followed by continuous intravenous infusion for 6 hours. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00288730
Study type Interventional
Source Scios, Inc.
Contact
Status Completed
Phase Phase 3
Start date October 1996
Completion date August 1997

See also
  Status Clinical Trial Phase
Completed NCT01357850 - A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure Phase 2
Recruiting NCT00532688 - N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure Phase 2/Phase 3
Completed NCT00531661 - CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients N/A
Terminated NCT00383630 - Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure Phase 2
Terminated NCT00125437 - Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy N/A
Completed NCT00241761 - Epidemiology of Depression and Heart Failure in Aging N/A
Completed NCT00149435 - Cardiovascular Health Study (CHS) Events Follow-up Study
Completed NCT00159614 - Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment Phase 2
Terminated NCT00357591 - Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation N/A
Completed NCT00094263 - Long-Term Predictors of Morbidity in Older Age N/A
Completed NCT00202579 - Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure Phase 2
Completed NCT00048425 - Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure. Phase 3
Completed NCT00023556 - Genetic Architecture of Heart Disease in Rural Brazil N/A
Completed NCT00530426 - Heart Failure Registry Phase 4
Terminated NCT00190359 - Growth Hormone and Heart Failure N/A
Completed NCT00004562 - Occluded Artery Trial (OAT) Phase 3
Completed NCT00005265 - Natural History of Coronary Heart Disease N/A
Completed NCT02772068 - Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a Early Phase 1
Completed NCT02925546 - A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets Phase 1
Completed NCT01074307 - A Prospective, Open-labeled, Multi-centric Trial in Subjects With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea Phase 4