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A Comparison of Recombinant Human Brain Natriuretic Peptide and Dobutamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01837849
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : April 23, 2013
Sponsor:
Information provided by (Responsible Party):
Haiyan PAN, Nantong University

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

Condition or disease
Acute Decompensated Heart Failure

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.

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Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparative Effects of Recombinant Human Brain Natriuretic Peptide and Dobutamine on Acute Decompensated Heart Failure Patients With Different Blood BNP Levels
Study Start Date : January 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. left ventricular ejection fraction (LVEF) in the High and Extra-high BNP Groups [ Time Frame: baseline and 5 days ]
  2. Left ventricle end diastolic dimension (LVEDD)in the High and Extra-high BNP Groups [ Time Frame: baseline and 5 days ]
  3. Blood BNP in the High and Extra-high BNP Groups [ Time Frame: baseline and 5 days ]

Secondary Outcome Measures :
  1. Changes in New York Heart Association (NYHA) Class from Baseline to Day 5 after Treatment [ Time Frame: baseline and 5 days ]
  2. Blood Pressure (mmHg) [ Time Frame: baseline and 5 days ]
  3. Heart Rate [ Time Frame: baseline and 5 days ]
  4. Plasma Creatinine [ Time Frame: baseline and 5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with acute decompensated heart failure who required hospitalization
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837849


Sponsors and Collaborators
Nantong University
Investigators
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Study Director: Jianhua Zhu, MD Nantong University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Haiyan PAN, associate chief physician, Nantong University
ClinicalTrials.gov Identifier: NCT01837849    
Other Study ID Numbers: AHNTU-2010-28
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013
Keywords provided by Haiyan PAN, Nantong University:
heart failure
rhBNP
Dobutamine
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Dobutamine
Natriuretic Peptide, Brain
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Natriuretic Agents