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Sponsored by: |
Scios, Inc. |
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Information provided by: | Scios, Inc. |
ClinicalTrials.gov Identifier: | NCT00475852 |
The purpose of this study is to find out if Nesiritide (a human B-type natriuretic peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart failure, helps to improve breathing difficulties, reduce readmissions to hospitals, and helps patients live longer.
Condition | Intervention | Phase |
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Heart Decompensation |
Drug: Placebo Drug: Nesiritide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF) |
Estimated Enrollment: | 7000 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | June 2011 |
Arms | Assigned Interventions |
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001: Experimental |
Drug: Nesiritide
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
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002: Placebo Comparator |
Drug: Placebo
matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
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Acute Decompensated Heart Failure (ADHF) is the inability of the heart to pump efficiently, which can result in symptoms like shortness of breath at rest or with minimal activity. ADHF is a condition in which the heart cannot perform the necessary circulation of blood through the body. This is a randomized (study medication is assigned by chance), double-blind (neither the patient or the doctor knows whether the patient is assigned to receive study drug or placebo [does not contain study drug]), placebo-controlled, parallel group, multicenter study of the effectiveness of Nesiritide administered continuously through a vein for a minimum of 24 hours up to a maximum of 7 days. The study hypothesis is that Nesiritide given in addition to standard care is superior to placebo given in addition to standard care as measured by relief of breathing difficulties (by patient evaluation utilizing a breathlessness scale) at 6 hours or 24 hours after Nesiritide administration, and reduction in rehospitalization due to heart failure and death from study drug administration through Day 30. The study drug (Nesiritide) or placebo dose being studied is 0.010 mcg/kg/min with or without a 2 mcg/kg initial bolus (one time injection) of Nesiritide. Patient safety will be monitored throughout the study through physical exams, vital signs (heart rate, blood pressure, respiratory rate, and temperature), blood tests, and side effects.
The patients assigned to the Nesiritide group will receive a continuous i.v. (into a vein) infusion at 0.010 mcg/kg/min of Nesiritide with or without a 2 mcg/kg bolus (one time injection). The patients assigned to the placebo group will receive matching placebo bolus and infusion. The bolus is given over one minute and the continuous infusion is given for at least 24 hours and up to 7 days
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Study Director: | Scios, Inc. Clinical Trial | Scios, Inc. |
Responsible Party: | Scios RD, Inc. ( Vice President, Associate Therapeutic Area Head ) |
Study ID Numbers: | CR013954, NATRECORAHF3002, ASCEND-HF, A093 |
Study First Received: | May 18, 2007 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00475852 History of Changes |
Health Authority: | United States: Food and Drug Administration |
decompensated nesiritide ADHF Dyspnea heart failure |
Natriuretic Peptide, Brain Heart Failure Heart Diseases Cardiovascular Agents Dyspnea |
Natriuretic Peptide, Brain Heart Failure Heart Diseases Natriuretic Agents Therapeutic Uses |
Physiological Effects of Drugs Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |