Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00842023
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : August 30, 2013
Last Update Posted : August 30, 2013
Sponsor:
Collaborator:
American College of Clinical Pharmacy
Information provided by (Responsible Party):
Sheryl Chow, Western University of Health Sciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Actual Primary Completion Date : July 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00842023


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Sheryl L. Chow, PharmD, FCCP, BCPS Western University of Heatlh Sciences
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Sheryl Chow, Associate Professor, Western University of Health Sciences
ClinicalTrials.gov Identifier: NCT00842023    
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
BNP
Heart Failure
Nitoglycerin
Biomarkers
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
 Nitroglycerin
Vasodilator Agents
Natriuretic Agents
Physiological Effects of Drugs