Clinical trial NCT01837849: A Comparison of Recombinant Human Brain Natriuretic Peptide and Dobutamine
Official title: Comparative Effects of Recombinant Human Brain Natriuretic Peptide and Dobutamine on Acute Decompensated Heart Failure Patients With Different Blood BNP Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Decompensated Heart Failure
Keywords: heart failure
rhBNP
Dobutamine
Lead sponsor: Nantong University
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute decompensated heart failure who required hospitalization

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.

Eligibility 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.

Primary outcomes:
measure: left ventricular ejection fraction (LVEF) in the High and Extra-high BNP Groups
timeFrame: baseline and 5 days
measure: Left ventricle end diastolic dimension (LVEDD)in the High and Extra-high BNP Groups
timeFrame: baseline and 5 days
measure: Blood BNP in the High and Extra-high BNP Groups
timeFrame: baseline and 5 days
Secondary outcomes:
measure: Changes in New York Heart Association (NYHA) Class from Baseline to Day 5 after Treatment
timeFrame: baseline and 5 days
measure: Blood Pressure (mmHg)
timeFrame: baseline and 5 days
measure: Heart Rate
timeFrame: baseline and 5 days
measure: Plasma Creatinine
timeFrame: baseline and 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Jianhua Zhu, MD
role: STUDY_DIRECTOR
References:
citation: 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.