Phase 4
N=89
Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy
Acute Decompensated Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00842023 ↗Enrolled (actual)
89
Serious AEs
27.0%
Results posted
Aug 2013
Primary outcome: Primary: Renal Function by Serum Creatinine — 1.3; 1.3; 1.3; 1.4 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nesiritide (Drug); Nitroglycerin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Western University of Health Sciences
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Function by Serum Creatinine |
1.3; 1.3; 1.3; 1.4; 1.3; 1.4 | — |
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.
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
- 2.5 mg/dL at the time of enrollment.
Data sourced from ClinicalTrials.gov (NCT00842023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.