Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy

Phase 4

Completed

• Conditions: Acute Decompensated Heart Failure
• Interventions: Drug: Nesiritide; Drug: Nitroglycerin

• Registration Number: NCT00842023
• Lead Sponsor: Western University of Health Sciences

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

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2008-07
• Study Completion: 2009-02
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-12
• Results First Submitted: 2012-02-03
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-29
• Last Update Submitted: 2013-08-29
• Results First Posted: 2013-08-30
• Last Update Posted: 2013-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nesiritide Infusion	Nesiritide	Nesiritide: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
Nitroglycerin Infusion	Nitroglycerin	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.

Primary Outcome Measures

Name	Time	Method
Renal Function by Serum Creatinine	Baseline, 24 hours, 48 hours	Serum creatinine values and changes in serum creatinine

Trial Locations

Locations (1)

Centinela Hospital Medical Center; 🇺🇸 Inglewood, California, United States