Double Blind Randomized Placebo Controlled Trial of Natrecor in Acute Decompensated Heart Failure With Normal EF
Heart failure (HF) is a disease that is caused by a reduced heart muscle function. Reduced heart muscle function can occur as a consequence of reduced pumping activity from a weak heart muscle or because of a stiff heart muscle. This study is looking at the effectiveness of Natrecor (nesiritide) in patients that require hospitalization due to worsening heart failure as a result of a stiff or thickened heart muscle. Natrecor is a man-made version of a protein that my body makes on its own and has been approved for the treatment of patients requiring hospital admission for heart failure and have shortness of breath at rest or with minimal activity.
Natrecor has shown to lower the pressures in the heart and decreases the congestion in the lungs. This study is being done to see if the addition of a Natrecor to standard medical therapy for HF will improve symptoms faster or more completely than giving only the standard treatment for CHF.
Heart Failure, Congestive
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Double Blind Randomized Placebo Controlled Trial of Natrecor in Patients Hospitalized for Decompensated Heart Failure in the Presence of a Normal Left Ventricular Ejection Fraction|
- The primary endpoint of this study will be an absolute reduction in brain natriuretic peptide (BNP) three hours after discontinuation of the study drug. [ Time Frame: Three hours after discontinuation of the study drug ] [ Designated as safety issue: Yes ]
- All cause in-hospital mortality [ Time Frame: 30 days post-randomization ] [ Designated as safety issue: Yes ]
- Physician and patient global score at 24 hours [ Time Frame: 30 days post-randomization ] [ Designated as safety issue: Yes ]
- Twenty-four hour urine output after start of study drug infusion [ Time Frame: 30 days post-randomization ] [ Designated as safety issue: Yes ]
- Weight change at 24 hours after start of study drug infusion [ Time Frame: 30 days post-randomization ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2007|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: Sugar pill
Lactose, NF (monohydrate)
Active Comparator: Nesiritide
Natrecor (nesiritide) is a commercially available B-type natriuretic peptide which is indicated for intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity.
Study drug will be administered for 24 hours. Study drug will be initiated with a 2-µg/kg loading bolus followed by .01-µg/kg/min infusion. This may be increased at a rate of .005-µg/kg/min. every 3 hours until maximum dose of .03-µg/kg/min. Any increase in the infusion rate will be preceded by a 1-µg/kg bolus and increases in infusion rates will be permitted only in patients who have a systolic blood pressure > 100 mmHg.
Other Name: Natrecor
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|United States, New Jersey|
|University of Medicine and Dentistry of New Jersey/ New Jersey Medical School|
|Newark, New Jersey, United States, 07103|
|Principal Investigator:||Marc Klapholz, MD||University of Medicine and Dentistry of New Jersey/ New Jersey Medical School|