Clinical trial NCT00842023: Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Decompensated Heart Failure
Keywords: Natriuretic peptides
BNP
Heart Failure
Nitoglycerin
Biomarkers
Lead sponsor: Western University of Health Sciences
Sponsor class: OTHER
Collaborators: name: American College of Clinical Pharmacy
First posted: 2009-02-12
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Renal Function by Serum Creatinine
timeFrame: Baseline, 24 hours, 48 hours
Secondary outcomes:
Other outcomes:
measure: Inflammatory Markers
timeFrame: 48 hours
measure: Serum Levels of Cystatin-C
timeFrame: Baseline, 24 hours, 48 hours
Locations:
city: Inglewood
country: United States
facility: Centinela Hospital Medical Center
state: California
Study officials:
affiliation: Western University of Heatlh Sciences
name: Sheryl L. Chow, PharmD, FCCP, BCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chow SL, O'Barr SA, Peng J, Chew E, Pak F, Quist R, Patel P, Patterson JH, Heywood JT. Renal function and neurohormonal changes following intravenous infusions of nitroglycerin versus nesiritide in patients with acute decompensated heart failure. J Card Fail. 2011 Mar;17(3):181-7. doi: 10.1016/j.cardfail.2010.10.005. Epub 2010 Dec 3.
citation: Chow SL, O'Barr SA, Peng J, Chew E, Pak F, Quist R, Patel P, Patterson JH, Heywood JT. Modulation of novel cardiorenal and inflammatory biomarkers by intravenous nitroglycerin and nesiritide in acute decompensated heart failure: an exploratory study. Circ Heart Fail. 2011 Jul;4(4):450-5. doi: 10.1161/CIRCHEARTFAILURE.110.958066. Epub 2011 May 16.