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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier:
NCT00813202
First received: December 18, 2008
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Heart Decompensation
Congestive Heart Failure
Drug: Nesiritide
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Xian-Janssen Pharmaceutical Ltd.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 41
Study Start Date: October 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nesiritide Drug: Nesiritide
Nesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs)

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813202

Locations
China
Beijing, China
Hangzhou, China
Shanghai, China
Xian, China
Sponsors and Collaborators
Xian-Janssen Pharmaceutical Ltd.
Investigators
Study Director: Xian-Janssen Pharmaceutical Ltd. Clinical Trial Xian-Janssen Pharmaceutical Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT00813202     History of Changes
Other Study ID Numbers: CR007573
Study First Received: December 18, 2008
Last Updated: February 26, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
Nesiritide
Natrecor
Quanke
Acute Decompensated Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014