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

This study has been completed.
Sponsor:
Collaborator:
American College of Clinical Pharmacy
Information provided by:
Western University of Health Sciences
ClinicalTrials.gov Identifier:
NCT00842023
First received: February 10, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 Intervention Phase
Acute Decompensated Heart Failure
 Drug: Nesiritide
Drug: nitroglycerin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

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

Further study details as provided by Western University of Health Sciences:

Primary Outcome Measures:
  • To determine the relationship between the infusion duration of nesiritide and nitroglycerin to nephrotoxicity [ Time Frame: Renal function markers will be evaluated at baseline, 24 hours, 48 hours, and at discharge. ] [ Designated as safety issue: Yes ]
  • Evaluate the effect of vasodilator therapy on neurohormonal and inflammatory biomarkers. [ Time Frame: The neurohormonal and inflammatory markers will be assessed at baseline, 24 hours and 48 hours from the start of infusion, and prior to discharge. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death or rehospitalization at 30 days and 6 months, median length of stay, total diuretic use while receiving infusion, need for dialysis, and symptomatic hypotension. [ Time Frame: Death or readmission will be evaluated at 30 days and at 6 months. ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: July 2006
Study Completion Date: July 2008
Arms Assigned Interventions
Experimental: Nesiritide infusion
Vasodilator therapy
 Drug: Nesiritide
Bolus 2 mcg/kg followed by 0.01 mcg/kg/min
Active Comparator: Nitroglycerin infusion
Vasodilator therapy
 Drug: nitroglycerin
5-10 mcg/min titrating per protocol based on blood pressure

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842023

Locations
United States, California
Centinela Hospital
Inglewood, California, United States, 90301
Sponsors and Collaborators
Western University of Health Sciences
American College of Clinical Pharmacy
Investigators
Principal Investigator: Sheryl L. Chow, PharmD Western University of Heatlh Sciences
  More Information

No publications provided by Western University of Health Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sheryl L. Chow, PharmD, Western University of Health Sciences
ClinicalTrials.gov Identifier: NCT00842023     History of Changes
Other Study ID Numbers: ACCP-26060
Study First Received: February 10, 2009
Last Updated: February 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Western University of Health Sciences:
Natriuretic peptides
BNP
Heart Failure
Nitoglycerin
Biomarkers

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Nitroglycerin
Vasodilator Agents
Natriuretic Peptide, Brain
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013