An Open-label, One-arm, Study to Evaluate the Hemodynamic Changes and Safety of Nesiritide for Acute Decompensated Heart Failure
The present study was an open-label, uncontrolled, and multi-centered phase III clinical trial for evaluation of the efficacy (clinical efficacy and hemodynamics) and safety of nesiritide.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Single Arm, Multi-centered Clinical Trial on the Hemodynamics and Safety of Nesiritide in the Treatment of Patients With Acute Decompensate Heart Failure|
- Change in pulmonary capillary wedge pressure [ Time Frame: Baseline, 180 days ] [ Designated as safety issue: No ]Pulmonary capillary wedge pressure will be measured in patients at all time points after administration of nesiritide, and the difference will be compared with baseline value (P<0.001).
- Change in clinical symptoms and overall clinical efficacy [ Time Frame: Baseline, 180 days ] [ Designated as safety issue: No ]Nesiritide will attenuate dyspnoea. Nesiritide will also improve clinical symptoms and Nesiritide will improve overall clinical efficacy.
|Study Start Date:||October 2006|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Nesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs)
This was an open-label, uncontrolled, and multi-centered phase II clinical trial for evaluation of the clinical efficacy and hemodynamics and safety of nesiritide. The study was conducted in hospital setting and all patients exhibited symptoms of acute decompensated heart failure, requiring treatment with intravenous drug administration. The total duration was 180 days, including a screening phase, an open treatment phase (24 hours in all) and a safety follow-up phase (day 30 and day 180). Screening phase: Right heart floating catheter was placed for patients with acute decompensate heart failure who met the inclusion criteria while not the exclusion criteria to measure pulmonary capillary wedge pressure. The results should be =20 mmHg. Open treatment phase: Nesiritide was administered by intravenous injection at a dose of 2 µg/kg for 60 second, followed by intravenous infusion at a dose of 0.01 µg/kg for 24 hour. All the patients were monitored for hemodynamics for 24 hour. Safety follow-up phase: On day 30, all the patients were required to return to the study center for follow-up. Information about death, severe adverse event, re-hospitalization and serum creatinine was collected. On day 180, all the patients were followed up by telephone. Information about death and severe adverse event was collected. Pulmonary capillary wedge pressure will be measured at 15 minutes, 1 hour, 3 hour and 24 hour, compared with baseline value. Nesiritide is white to off-white sterile lyophilized lump or powder, supplied in transparent 5 mL glass vials. The investigational drug was administered via infusion pump. Infusion rate was adjusted according to body weight. The drug was administered directly via venous cannula or the nearest injection port to the venous cannula for 60 second. The dosage of nesiritide was 2 µg/kg. The infusion rate of nesiritide was adjusted to 0.01 µg/kg/min (cannot exceed 0.01 µg/kg/min).
|Study Director:||Xian-Janssen Pharmaceutical Ltd. Clinical Trial||Xian-Janssen Pharmaceutical Ltd.|