NCT00842023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

August 30, 2013

Completed
Last Updated

August 30, 2013

Status Verified

August 1, 2013

Enrollment Period

2 years

First QC Date

February 10, 2009

Results QC Date

February 3, 2012

Last Update Submit

August 29, 2013

Conditions

Acute Decompensated Heart Failure

Keywords

Natriuretic peptidesBNPHeart FailureNitoglycerinBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Renal Function by Serum Creatinine

    Serum creatinine values and changes in serum creatinine

    Baseline, 24 hours, 48 hours

Other Outcomes (2)

  • Inflammatory Markers

    48 hours

  • Serum Levels of Cystatin-C

    Baseline, 24 hours, 48 hours

Study Arms (2)

Nesiritide Infusion

EXPERIMENTAL

Nesiritide: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.

Drug: Nesiritide

Nitroglycerin Infusion

ACTIVE COMPARATOR

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

Interventions

NesiritideDRUG

Bolus 2 mcg/kg followed by 0.01 mcg/kg/min

Nesiritide Infusion
NitroglycerinDRUG

5-10 mcg/min titrating per protocol based on blood pressure

Nitroglycerin Infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \<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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centinela Hospital Medical Center

Inglewood, California, 90301, United States

Location

Related Publications (2)

  • 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.

    PMID: 21362524RESULT

  • 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.

    PMID: 21576282RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

Natriuretic Peptide, BrainNitroglycerin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteinsNitro CompoundsOrganic Chemicals

Results Point of Contact

Title
Dr. Sheryl L. Chow
Organization
Western University of Health Sciences
schow@westernu.edu
9094695379

Study Officials

  • Sheryl L. Chow, PharmD, FCCP, BCPS

    Western University of Heatlh Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 12, 2009

Study Start

July 1, 2006

Primary Completion

July 1, 2008

Study Completion

February 1, 2009

Last Updated

August 30, 2013

Results First Posted

August 30, 2013

Record last verified: 2013-08

Locations

US(1)