Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy
Information source: Western University of Health Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Decompensated Heart Failure
Intervention: Nesiritide (Drug); Nitroglycerin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Western University of Health Sciences Official(s) and/or principal investigator(s):
Sheryl L. Chow, PharmD, FCCP, BCPS, Principal Investigator, Affiliation: Western University of Heatlh Sciences
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.
Clinical Details
Official title: A Randomized Controlled Trial to Evaluate Renal Function, Inflammatory Mediators, and Neurohormonal Markers in Acutely Decompensated Heart Failure Patients Receiving Nesiritide Compared to Nitroglycerin.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Renal Function by Serum Creatinine
Detailed description:
No additional details provided
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Centinela Hospital Medical Center, Inglewood, California 90301, United States
Additional Information
Starting date: July 2006
Last updated: August 29, 2013
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