Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT00271557
Brief Summary:
The purpose of this safety study is to evaluate NATRECOR® hBNP (a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure), in subjects with worsening congestive heart failure for whom inpatient intravenous therapy with medications that influence the tone and caliber of blood vessels is deemed appropriate.
Detailed Description:
The data from these previous studies suggest that doses of NATRECOR® 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. The purpose of this safety study is to evaluate NATRECOR® hBNP in subjects with symptomatic, decompensated congestive heart failure for whom inpatient intravenous therapy with medications that influence the tone and caliber of blood vessels (other than, or in addition to, IV diuretics) is deemed appropriate. This is a multi-center, randomized, open-label, safety study designed to compare two doses of NATRECOR® hBNP for the treatment of decompensated congestive heart failure. One treatment group receives NATRECOR® hBNP fixed-dose infusion IV bolus of 0.3 µg/kg followed by a 0.015 µg/kg/min infusion; group two receives IV bolus of 0.6 µg/kg followed by a 0.03 µg/kg/min infusion. The duration of NATRECOR® hBNP therapy is determined by the attending physician. The study hypothesis is that doses of NATRECOR® hBNP in the range of 0.015 to 0.03 µg/kg/min provide an optimal safety/efficacy profile for the treatment of decompensated CHF. One treatment group receives NATRECOR® hBNP fixed-dose infusion IV bolus of 0.3 µg/kg followed by a 0.015 µg/kg/min infusion; group two receives IV bolus of 0.6 µg/kg followed by a 0.03 µg/kg/min infusion. The duration of NATRECOR® hBNP therapy is determined by the attending physician.
Study:
NCT00271557
Study Brief:
Protocol Section:
NCT00271557