Acute Decompensated Heart FailureNCT01837849
A Comparison of Recombinant Human Brain Natriuretic Peptide and Dobutamine
An observational study of Acute Decompensated Heart Failure, run by Nantong University.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute decompensated heart failure who required hospitalization
Who may be able to join
- patients were classified as NYHA class III-IV
- ejection fraction <40%
Who cannot join
- 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
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- hypovolemia
- hepatic or renal impairment
- pregnant and lactating women.
About this study
Official title: Comparative Effects of Recombinant Human Brain Natriuretic Peptide and Dobutamine on Acute Decompensated Heart Failure Patients With Different Blood BNP Levels
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
Read the 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.
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- heart failure, rhBNP, Dobutamine
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular ejection fraction (LVEF) in the High and Extra-high BNP Groups
Measured: baseline and 5 days
Left ventricle end diastolic dimension (LVEDD)in the High and Extra-high BNP Groups
Measured: baseline and 5 days
Blood BNP in the High and Extra-high BNP Groups
Measured: baseline and 5 days
Secondary outcomes (4)
Changes in New York Heart Association (NYHA) Class from Baseline to Day 5 after Treatment
Measured: baseline and 5 days
Blood Pressure (mmHg)
Measured: baseline and 5 days
Heart Rate
Measured: baseline and 5 days
Plasma Creatinine
Measured: baseline and 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiyan PAN, Nantong University
- Investigators
- Jianhua Zhu, MD, Study director, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837849
- Sponsor's protocol ID
- AHNTU-2010-28
- Status last verified
- Apr 2013
- First submitted
- 12 Apr 2013
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24593826
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Recombinant Human Brain Natriuretic Peptide and Dobutamine on Acute Decompensated Heart Failure Patients With Different Blood BNP Levels
- ClinicalTrials.gov ID
- NCT01837849
- Acronym / sponsor ID
- AHNTU-2010-28
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- heart failure, rhBNP, Dobutamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Nantong UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute decompensated heart failure who required hospitalization
Key inclusion criteria (2 listed)
- patients were classified as NYHA class III-IV
- ejection fraction <40%
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
left ventricular ejection fraction (LVEF) in the High and Extra-high BNP Groups
Time frame: baseline and 5 days
Left ventricle end diastolic dimension (LVEDD)in the High and Extra-high BNP Groups
Time frame: baseline and 5 days
Blood BNP in the High and Extra-high BNP Groups
Time frame: baseline and 5 days
4 secondary outcomes
Changes in New York Heart Association (NYHA) Class from Baseline to Day 5 after Treatment
Time frame: baseline and 5 days
Blood Pressure (mmHg)
Time frame: baseline and 5 days
Heart Rate
Time frame: baseline and 5 days
Plasma Creatinine
Time frame: baseline and 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
- Derived from this study: PubMed 24593826Pan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianhua Zhu, MD study director
Affiliated Hospital of Nantong University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Decompensated Heart Failure, run by Nantong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular ejection fraction (LVEF) in the High and Extra-high BNP Groups (time frame: baseline and 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01837849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.