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

NCT00813202 | Completed Phase 3

• 1 other identifier: CR007573
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Heart Decompensation; Congestive Heart Failure

Keywords

Nesiritide; Natrecor; Quanke; Acute Decompensated Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in pulmonary capillary wedge pressure

  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).

  Baseline, 180 days

Secondary Outcomes (1)

• Change in clinical symptoms and overall clinical efficacy

  Baseline, 180 days

Study Arms (1)

Nesiritide

EXPERIMENTAL

Drug: Nesiritide

Interventions

Nesiritide DRUG

Nesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs)

Nesiritide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (4)

Unknown Facility

Beijing, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Xi'an, China

Location

Related Links

• 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

MeSH Terms

Conditions

Heart Failure

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Xian-Janssen Pharmaceutical Ltd. Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 22, 2008
• Study Start: October 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

CN (4)