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Completed

NCT Number: NCT01837849

A Comparison of Recombinant Human Brain Natriuretic Peptide and Dobutamine

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

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Key information

Conditions

Acute Decompensated Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantong University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 23, 2013
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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