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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00842023
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : August 30, 2013
Last Update Posted : August 30, 2013
American College of Clinical Pharmacy
Information provided by (Responsible Party):
Sheryl Chow, Western University of Health Sciences

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.

Condition or disease Intervention/treatment Phase
Acute Decompensated Heart Failure Drug: Nesiritide Drug: Nitroglycerin Phase 4

Detailed Description:
No additional details provided

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2006
Primary Completion Date : July 2008
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Renal Function by Serum Creatinine [ Time Frame: Baseline, 24 hours, 48 hours ]
    Serum creatinine values and changes in serum creatinine

Other Outcome Measures:
  1. Inflammatory Markers [ Time Frame: 48 hours ]

  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00842023

United States, California
Centinela Hospital Medical Center
Inglewood, California, United States, 90301
Sponsors and Collaborators
Western University of Health Sciences
American College of Clinical Pharmacy
Principal Investigator: Sheryl L. Chow, PharmD, FCCP, BCPS Western University of Heatlh Sciences

Publications of Results:
Responsible Party: Sheryl Chow, Associate Professor, Western University of Health Sciences Identifier: NCT00842023     History of Changes
Other Study ID Numbers: ACCP-26060
First Posted: February 12, 2009    Key Record Dates
Results First Posted: August 30, 2013
Last Update Posted: August 30, 2013
Last Verified: August 2013

Keywords provided by Sheryl Chow, Western University of Health Sciences:
Natriuretic peptides
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Cardio-Renal Syndrome
Heart Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Natriuretic Peptide, Brain
Vasodilator Agents
Natriuretic Agents
Physiological Effects of Drugs