A Comparison of Recombinant Human Brain Natriuretic Peptide and Dobutamine

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01837849

Enrollment

104

Registered

2013-04-23

Start date

2011-01-31

Completion date

2012-06-30

Last updated

2013-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Decompensated Heart Failure

Keywords

heart failure, rhBNP, Dobutamine

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
Blood Pressure (mmHg)	baseline and 5 days
Heart Rate	baseline and 5 days

Outcome results