A Comparison of Recombinant Human Brain Natriuretic Peptide and Dobutamine

April 18, 2013 updated by: Haiyan PAN, Nantong University

Comparative Effects of Recombinant Human Brain Natriuretic Peptide and Dobutamine on Acute Decompensated Heart Failure Patients With Different Blood BNP Levels

To compare the therapeutic efficacy of recombinant human brain natriuretic peptide (rhBNP) with dobutamine on acute decompensated heart failure patients with different blood BNP levels

Study Overview

Status

Completed

Conditions

Detailed Description

Patients with acute decompensated heart failure (ADHF) whose left ventricular ejection fraction(LVEF) was <40%, were assigned to a high BNP group (BNP ≤ 3000 pg/mL) or an extra-high BNP group (BNP > 3000 pg/mL) , depending on their admission plasma BNP levels. Each group was then subdivided into rhBNP or dobutamine subgroups according to intravenous administration with either rhBNP or dobutamine for 24-72h. The effects of rhBNP and dobutamine on patients in the high and extra-high BNP groups were compared.

Study Type

Observational

Enrollment (Actual)

104

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

Sampling Method

Probability Sample

Study Population

Patients with acute decompensated heart failure who required hospitalization

Description

Inclusion Criteria:

  • patients were classified as NYHA class III-IV
  • ejection fraction <40%

Exclusion Criteria:

  • intravenous administration with rhBNP or dobutamine in the 2 weeks before study entry
  • acute myocardial infarction
  • significant valvular stenosis
  • serious ventricular arrhythmia (frequent ventricular premature beat of >5 bpm, nonsustained and sustained ventricular tachycardia)
  • blood pressure <95/60 mmHg or >140/90 mmHg
  • shock
  • hypovolemia
  • hepatic or renal impairment
  • pregnant and lactating women.

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
left ventricular ejection fraction (LVEF) in the High and Extra-high BNP Groups
Time Frame: baseline and 5 days
baseline and 5 days
Left ventricle end diastolic dimension (LVEDD)in the High and Extra-high BNP Groups
Time Frame: baseline and 5 days
baseline and 5 days
Blood BNP in the High and Extra-high BNP Groups
Time Frame: baseline and 5 days
baseline and 5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in New York Heart Association (NYHA) Class from Baseline to Day 5 after Treatment
Time Frame: baseline and 5 days
baseline and 5 days
Blood Pressure (mmHg)
Time Frame: baseline and 5 days
baseline and 5 days
Heart Rate
Time Frame: baseline and 5 days
baseline and 5 days
Plasma Creatinine
Time Frame: baseline and 5 days
baseline and 5 days

Collaborators and Investigators

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

Sponsor

Nantong University

Investigators

  • Study Director: Jianhua Zhu, MD, Affiliated Hospital of Nantong University

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

January 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

April 18, 2013

First Posted (Estimate)

April 23, 2013

Study Record Updates

Last Update Posted (Estimate)

April 23, 2013

Last Update Submitted That Met QC Criteria

April 18, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHNTU-2010-28

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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