Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy (ABC-HFT)

Western University of Health Sciences (WESTERN U)

Status and phase: Completed; Phase 4

Conditions: Acute Decompensated Heart Failure

Treatments: Drug: Nitroglycerin; Drug: Nesiritide

Study type: Interventional

Funder types: Other

Identifiers

NCT00842023

ACCP-26060

Details and patient eligibility

About

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.

Full description

No additional details provided

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

Nesiritide Infusion

Experimental group

Description:

Nesiritide: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.

Treatment:

Drug: Nesiritide

Nitroglycerin Infusion

Active Comparator group

Description:

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.

Treatment:

Drug: Nitroglycerin