A Study Comparing Blood Flow and Clinical and Safety Effects of the Addition of Natrecor (Nesiritide), Placebo or Intravenous Nitroglycerin to Standard Care for the Treatment of Worsening Congestive Heart Failure.

Summary

The purpose of this study is to compare the hemodynamic (blood flow) and clinical effects of the study drug, Natrecor (nesiritide, a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) to those of intravenous nitroglycerin or placebo, when added to the standard care therapy that is usually administered in the treatment of patients with worsening congestive heart failure.

Timeline

Start

1999-10

Primary completion

—

Completion

2000-08

Outcome

Met primary endpoint

paper At 3 hours, the mean (SD) decrease in PCWP from baseline was -5.8 (6.5) mm Hg for nesiritide (vs placebo, P<.001; PMID 11911755 ↗

paper At 3 hours, nesiritide resulted in improvement in dyspnea compared with placebo (P =.03), PMID 11911755 ↗

Publications

• Results Publication Committee for the VMAC Investigators (Vasodilatation in the Management of Acute CHF). Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure: a randomized controlled trial. JAMA. 2002 Mar 27;287(12):1531-40. doi: 10.1001/jama.287.12.1531.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nesiritide	Protein / enzyme biologic	0.01 ug/kg	Intravenous

Indications