MedDataX Logo

Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy

NCT ID: NCT00842023

Last Updated: 2013-08-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

No additional details provided

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Decompensated Heart Failure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Natriuretic peptides BNP Heart Failure Nitoglycerin Biomarkers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nesiritide Infusion

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

Group Type EXPERIMENTAL

Nesiritide

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Nitroglycerin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nesiritide

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

Intervention Type DRUG

Nitroglycerin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

American College of Clinical Pharmacy

OTHER

Sponsor Role collaborator

Western University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sheryl Chow

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sheryl L. Chow, PharmD, FCCP, BCPS

Role: PRINCIPAL_INVESTIGATOR

Western University of Heatlh Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centinela Hospital Medical Center

Inglewood, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 21362524 (View on PubMed)

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.

Reference Type RESULT
PMID: 21576282 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ACCP-26060

Identifier Type: -

Identifier Source: org_study_id