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OpenTrials
Completed

NCT Number: NCT00842023

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

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.

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Key information

Conditions

Acute Decompensated Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centinela Hospital Medical Center

Inglewood, California, 90301, United States

About this study

No additional details provided

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nesiritide

Drug

Bolus 2 mcg/kg followed by 0.01 mcg/kg/min

Nitroglycerin

Drug

5-10 mcg/min titrating per protocol based on blood pressure

Primary outcomes

  1. Renal Function by Serum Creatinine

    Time frame: Baseline, 24 hours, 48 hours

    Serum creatinine values and changes in serum creatinine

Other outcomes

  1. Inflammatory Markers

    Time frame: 48 hours

    Interleukin-6

  2. Serum Levels of Cystatin-C

    Time frame: Baseline, 24 hours, 48 hours

    Cystatin-C is a protease inhibitor and a sensitive endogenous marker of renal function.

Sponsors and collaborators

Lead sponsor

Western University of Health Sciences

Other

Collaborators

  • American College of Clinical Pharmacy

Registry information

Official study 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.

Acronym: ABC-HFT

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Feb 12, 2009
Registry last updated
Aug 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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