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 (Responsible Party):
Sheryl Chow, Western University of Health Sciences
ClinicalTrials.gov Identifier:
NCT00842023
First received: February 10, 2009
Last updated: August 29, 2013
Last verified: August 2013

February 10, 2009
August 29, 2013
July 2006
July 2008   (final data collection date for primary outcome measure)
Renal Function by Serum Creatinine [ Time Frame: Baseline, 24 hours, 48 hours ] [ Designated as safety issue: Yes ]
Serum creatinine values and changes in serum creatinine
  • 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 ]
Complete list of historical versions of study NCT00842023 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
  • Inflammatory Markers [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Interleukin-6
  • Serum Levels of Cystatin-C [ Time Frame: Baseline, 24 hours, 48 hours ] [ Designated as safety issue: No ]
    Cystatin-C is a protease inhibitor and a sensitive endogenous marker of renal function.
Not Provided
 
Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy
A Randomized Controlled Trial to Evaluate Renal Function, Inflammatory Mediators, and Neurohormonal Markers in Acutely Decompensated Heart Failure Patients Receiving Nesiritide Compared to Nitroglycerin.

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.

No additional details provided

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Decompensated Heart Failure
  • Drug: Nesiritide
    Bolus 2 mcg/kg followed by 0.01 mcg/kg/min
  • Drug: Nitroglycerin
    5-10 mcg/min titrating per protocol based on blood pressure
  • Experimental: Nesiritide Infusion
    Nesiritide: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
    Intervention: Drug: Nesiritide
  • 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.
    Intervention: Drug: Nitroglycerin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
February 2009
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00842023
ACCP-26060
Yes
Sheryl Chow, Western University of Health Sciences
Western University of Health Sciences
American College of Clinical Pharmacy
Principal Investigator: Sheryl L. Chow, PharmD, FCCP, BCPS Western University of Heatlh Sciences
Western University of Health Sciences
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP