NCT01837849

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

1.4 years

First QC Date

April 12, 2013

Last Update Submit

April 18, 2013

Conditions

Acute Decompensated Heart Failure

Keywords

heart failurerhBNPDobutamine

Outcome Measures

Primary Outcomes (3)

  • left ventricular ejection fraction (LVEF) in the High and Extra-high BNP Groups

    baseline and 5 days

  • Left ventricle end diastolic dimension (LVEDD)in the High and Extra-high BNP Groups

    baseline and 5 days

  • Blood BNP in the High and Extra-high BNP Groups

    baseline and 5 days

Secondary Outcomes (4)

  • Changes in New York Heart Association (NYHA) Class from Baseline to Day 5 after Treatment

    baseline and 5 days

  • Blood Pressure (mmHg)

    baseline and 5 days

  • Heart Rate

    baseline and 5 days

  • Plasma Creatinine

    baseline and 5 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with acute decompensated heart failure who required hospitalization

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Pan HY, Zhu JH, Gu Y, Yu XH, Pan M, Niu HY. Comparative effects of recombinant human brain natriuretic peptide and dobutamine on acute decompensated heart failure patients with different blood BNP levels. BMC Cardiovasc Disord. 2014 Mar 4;14:31. doi: 10.1186/1471-2261-14-31.

    PMID: 24593826DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jianhua Zhu, MD

    Affiliated Hospital of Nantong University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

April 12, 2013

First Posted

April 23, 2013

Study Start

January 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

April 23, 2013

Record last verified: 2013-04