An Open-label, One-arm, Study to Evaluate the Hemodynamic Changes and Safety of Nesiritide for Acute Decompensated Heart Failure

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xian-Janssen Pharmaceutical Ltd.
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

• Systolic blood pressure> 90 mmHg

• The subjects must present with dyspnoea at resting state or with minimum activity amount (such as standing up)

• Onset at this time was complicated with symptoms of acute decompensate heart failure, and it was serious enough to call for hospitalization and treatment with intravenous drug administration

• Acute decompensate heart failure was caused by cardiogenic factors rather than pulmonary factors (for example, it was neither cor pulmonale nor chronic heart failure complicated with pneumonia)

• The patients must have at least two of manifestations that related with this acute onset.

Exclusion Criteria:

• Patients with systolic blood pressure =90 mmHg

• patients who had been administered with intravenous nitroglycerin or other intravenous vasoactive drugs within 2 hour before administration of the investigational drug

• Patients who had known or suspected acute coronary syndrome (Myocardial infarction with or without increased ST segment, or unstable myocardial infarction) within 2 weeks before administration of the investigational drug

• Patients with cardiac shock or clinical manifestation of uncorrected hypovolemia or sodium depletion (such as clinical signs of excessive diuresis or dehydration), or clinical manifestation induced by other forbidden venous vasoactive agents

• Patients with such extremely emergent and unstable clinical conditions that not tolerant to Swan-Ganz catheter or temporal baseline evaluation

• patients with obvious cardiac valvular stenosis (subjects treated by valve-replacement can be included), hypertrophic, restrictive, or obstructive myocardial disease, primary pulmonary hypertension, or complex congenital heart disease.