Back to resultsAssessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy (ABC-HFT)
Primary Purpose
Acute Decompensated Heart Failure
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nesiritide
Nitroglycerin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Decompensated Heart Failure focused on measuring Natriuretic peptides, BNP, Heart Failure, Nitoglycerin, Biomarkers
Eligibility 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.
Sites / Locations
- Centinela Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nesiritide Infusion
Nitroglycerin Infusion
Arm Description
Nesiritide: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
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.
Outcomes
Primary Outcome Measures
Renal Function by Serum Creatinine
Serum creatinine values and changes in serum creatinine
Secondary Outcome Measures
Full Information
NCT ID
NCT00842023
First Posted
February 10, 2009
Last Updated
August 29, 2013
Sponsor
Western University of Health Sciences
Collaborators
American College of Clinical Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT00842023
Brief Title
Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy
Acronym
ABC-HFT
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 Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University of Health Sciences
Collaborators
American College of Clinical Pharmacy
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
No additional details provided
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure
Keywords
Natriuretic peptides, BNP, Heart Failure, Nitoglycerin, Biomarkers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nesiritide Infusion
Arm Type
Experimental
Arm Description
Nesiritide: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
Arm Title
Nitroglycerin Infusion
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Nesiritide
Intervention Description
Bolus 2 mcg/kg followed by 0.01 mcg/kg/min
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Intervention Description
5-10 mcg/min titrating per protocol based on blood pressure
Primary Outcome Measure Information:
Title
Renal Function by Serum Creatinine
Description
Serum creatinine values and changes in serum creatinine
Time Frame
Baseline, 24 hours, 48 hours
Other Pre-specified Outcome Measures:
Title
Inflammatory Markers
Description
Interleukin-6
Time Frame
48 hours
Title
Serum Levels of Cystatin-C
Description
Cystatin-C is a protease inhibitor and a sensitive endogenous marker of renal function.
Time Frame
Baseline, 24 hours, 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheryl L. Chow, PharmD, FCCP, BCPS
Organizational Affiliation
Western University of Heatlh Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centinela Hospital Medical Center
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21362524
Citation
Chow SL, O'Barr SA, Peng J, Chew E, Pak F, Quist R, Patel P, Patterson JH, Heywood JT. Renal function and neurohormonal changes following intravenous infusions of nitroglycerin versus nesiritide in patients with acute decompensated heart failure. J Card Fail. 2011 Mar;17(3):181-7. doi: 10.1016/j.cardfail.2010.10.005. Epub 2010 Dec 3.
Results Reference
result
PubMed Identifier
21576282
Citation
Chow SL, O'Barr SA, Peng J, Chew E, Pak F, Quist R, Patel P, Patterson JH, Heywood JT. Modulation of novel cardiorenal and inflammatory biomarkers by intravenous nitroglycerin and nesiritide in acute decompensated heart failure: an exploratory study. Circ Heart Fail. 2011 Jul;4(4):450-5. doi: 10.1161/CIRCHEARTFAILURE.110.958066. Epub 2011 May 16.
Results Reference
result
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Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy
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