A Comparison of Recombinant Human Brain Natriuretic Peptide and Dobutamine

Completed

• Conditions: Acute Decompensated Heart Failure

• Registration Number: NCT01837849
• Lead Sponsor: 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

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 Timeline

• Study Start: 2011-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-04
• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-04-18
• Last Update Submitted: 2013-04-18
• Study First Posted: 2013-04-23
• Last Update Posted: 2013-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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