A Comparison of Recombinant Human Brain Natriuretic Peptide and Dobutamine

Acute Decompensated Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837849
• Other study ID #: AHNTU-2010-28
• Status: Completed
• Phase: N/A
• First received: April 12, 2013
• Last updated: April 18, 2013
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: April 2013
• Source: Nantong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular ejection fraction (LVEF) in the High and Extra-high BNP Groups		baseline and 5 days	No
Primary	Left ventricle end diastolic dimension (LVEDD)in the High and Extra-high BNP Groups		baseline and 5 days	No
Primary	Blood BNP in the High and Extra-high BNP Groups		baseline and 5 days	No
Secondary	Changes in New York Heart Association (NYHA) Class from Baseline to Day 5 after Treatment		baseline and 5 days	No
Secondary	Blood Pressure (mmHg)		baseline and 5 days	No
Secondary	Heart Rate		baseline and 5 days	No
Secondary	Plasma Creatinine		baseline and 5 days	No