A Randomized Controlled Trial to Evaluate Renal Function, Inflammatory Mediators, and Neurohormonal Markers in Acutely Decompensated Heart Failure Patients Receiving Nesiritide Compared to Nitroglycerin.
Overview
- Phase
- Phase 4
- Intervention
- Nesiritide
- Conditions
- Acute Decompensated Heart Failure
- Sponsor
- Western University of Health Sciences
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Renal Function by Serum Creatinine
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to determine whether Nesiritide is more effective than nitroglycerin in modifying inflammatory and neurohormonal biomarkers without renal toxicity when proper infusion duration is administered.
Detailed Description
No additional details provided
Investigators
Sheryl Chow
Associate Professor
Western University of Health Sciences
Eligibility Criteria
Inclusion Criteria
- •At least 18 years of age.
- •Subject must be able to understand the potential risks and benefits associated with the study.
- •Baseline systolic blood pressure ≥ 90 mm Hg at the time of enrollment.
- •Clinical symptoms of dyspnea and laboratory admission BNP levels \> 500 pg/mL.
- •Neither pregnant or breastfeeding at the time of enrollment.
- •Authorization of patient's enrollment by patient's medical provider.
Exclusion Criteria
- •\<18 years of age
- •Denies written informed consent
- •Pregnant or lactating.
- •Baseline systolic BP \< 90 mmHg or cardiogenic shock
- •No symptoms of congestion or admission BNP \< 500 pg/mL
- •Known allergy to E.coli-derived products, or any history of anaphylactic reactions to nesiritide.
- •Receiving dialysis at the time of enrollment.
- •Serum creatinine \> 2.5 mg/dL at the time of enrollment.
Arms & Interventions
Nesiritide Infusion
Nesiritide: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
Intervention: Nesiritide
Nitroglycerin Infusion
Nitroglycerin was initiated at 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP\<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
Intervention: Nitroglycerin
Outcomes
Primary Outcomes
Renal Function by Serum Creatinine
Time Frame: Baseline, 24 hours, 48 hours
Serum creatinine values and changes in serum creatinine