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

Study Overview
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Brief Summary
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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
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No additional details provided

Official Title
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A Randomized Controlled Trial to Evaluate Renal Function, Inflammatory Mediators, and Neurohormonal Markers in Acutely Decompensated Heart Failure Patients Receiving Nesiritide Compared to Nitroglycerin.

Conditions
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Acute Decompensated Heart Failure

Intervention / Treatment
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* Drug: Nesiritide
* Drug: Nitroglycerin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nesiritide Infusion<br>Nesiritide: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours. | Drug: Nesiritide<br>* Bolus 2 mcg/kg followed by 0.01 mcg/kg/min<br>|
| Active Comparator: Nitroglycerin Infusion<br>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. | Drug: Nitroglycerin<br>* 5-10 mcg/min titrating per protocol based on blood pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Function by Serum Creatinine | Serum creatinine values and changes in serum creatinine | Baseline, 24 hours, 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BNP, Natriuretic peptides, Heart Failure, Nitoglycerin, Biomarkers