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

August 29, 2013 updated by: Sheryl Chow, Western University of Health Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

No additional details provided

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Inglewood, California, United States, 90301
        • Centinela Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Function by Serum Creatinine
Time Frame: Baseline, 24 hours, 48 hours
Serum creatinine values and changes in serum creatinine
Baseline, 24 hours, 48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory Markers
Time Frame: 48 hours
Interleukin-6
48 hours
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.
Baseline, 24 hours, 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University of Health Sciences

Collaborators

American College of Clinical Pharmacy

Investigators

  • Principal Investigator: Sheryl L. Chow, PharmD, FCCP, BCPS, Western University of Heatlh Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Estimate)

August 30, 2013

Last Update Submitted That Met QC Criteria

August 29, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACCP-26060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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