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
  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:


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

Primary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Enrollment: 89
Study Start Date: July 2006
Study Completion Date: February 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

No additional details provided

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842023

Locations
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
Investigators
Principal Investigator: Sheryl L. Chow, PharmD, FCCP, BCPS Western University of Heatlh Sciences
  More Information

Publications:
Responsible Party: Sheryl Chow, Associate Professor, Western University of Health Sciences
ClinicalTrials.gov Identifier: NCT00842023     History of Changes
Other Study ID Numbers: ACCP-26060
Study First Received: February 10, 2009
Results First Received: February 3, 2012
Last Updated: August 29, 2013
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
Natriuretic Peptide, Brain
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014