Congestive Heart FailureNCT00534066
Utility of Serial BNP Levels in Emergency Department CHF
An observational study of Congestive Heart Failure, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of the study is to determine if a series of BNP blood tests performed on patients who present to the Emergency Department with congestive heart failure (CHF) can predict which patients may have adverse outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Jun 2006
- 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
Who may be able to join
- age18 or older
- primary diagnosis of CHF in the Emergency Department
- admission to the hospital or transfer to the Observation Unit
Who cannot join
- minors, prisoners,pregnant women,unable to provide consent
- unstable angina or acute myocardial infarction in the ED
- dialysis dependent patients
- use of nesiritide as a therapy in the ED
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: The Utility of Serial BNP Levels as a Predictor of Adverse Outcomes in Emergency Department CHF
The purpose of the study is to determine if a series of BNP blood tests performed on patients who present to the Emergency Department with congestive heart failure (CHF) can predict which patients may have adverse outcomes. If the BNP is shown to be predictive of bad outcomes in certain patients, those patients might receive more intensive therapy early to prevent such outcomes. This was a prospective trial enrolling patients who presented to the ED and were diagnosed with heart failure. Subjects had a blood test for BNP, which is elevated in the presence of heart failure, collected twelve hours after their initial clinical BNP was obtained in the ED. Demographics, history, length of hospital stay, and other approved data were collected. At 30 days and 6 months after discharge, a follow up call was made to determine if the subject had required additional emergency care, had been admitted to a hospital, or had died during that period of time.
Read the detailed description
BNP is a 32-amino acid peptide secreted almost exclusively by the ventricles under conditions of ventricular wall strain.Multiple studies have examined the utility of BNP as a marker of decompensated heart failure, both in the inpatient and outpatient settings. Several studies have examined the use of a single BNP measure to predict adverse outcomes in CHF patients. Typical study designs have utilized CHF specialty clinics or patients admitted for congestive heart failure (CHF) exacerbation as the study population. Very few studies have utilized BNP in the acute care setting; these studies have also used BNP as a single measure. As the serum half-life of BNP is approximately 22 minutes,BNP levels will respond to measures decreasing ventricular wall strain, such that a decreasing BNP level should be diagnostic of improved CHF. It is our hypothesis that Emergency Department patients with acute CHF exacerbation and a decreasing serum BNP level after 12 hours of therapy will demonstrate an improved outcome when compared to patients whose BNP does not decrease.
Our goal is to establish the utility of serial BNP levels during the intensive initial management of acute CHF. One and six month follow-up patient outcomes will be collected and compared against the serial BNP measurements while the patient was in the acute phase of treatment. It is our hypothesis that serial brain natriuretic peptide (BNP) levels compared at 0 and 12 hours for research purposes will be predictive of a combined endpoint of death, readmission, or repeat Emergency Department visit for recurrent CHF in patients presenting to the Emergency Department with an acute exacerbation of CHF.
To date, no data has been published regarding the utility of serial BNP measurements in the observation unit management of CHF. Our study proposes to compare outcomes in patients managed in the Clinical Decision Unit (CDU), a six bed observation unit in our Emergency Department, against patients admitted for CHF exacerbation. The primary outcome of the study will be the combined endpoint of death, readmission, or repeat Emergency Department visit for recurrent CHF at 30 days and 6 months. For inpatients, and those patients admitted from the CDU to the inpatient service, additional outcome measures will be adverse outcomes (intubation, balloon pump, death, etc) during the index hospitalization. As the clinicians managing the patient will not have access to the 12 hour BNP level, the measurement of BNP itself will not be a source of bias. Our secondary hypothesis is that the occurrence of the combined endpoint will be independent of treatment location (CDU vs inpatient) as opposed to responder vs. non-responder status.
- Conditions
- Congestive Heart Failure
- Keywords
- Natriuretic Peptide, Brain
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Admitted | Patients presenting to the ED with acute exacerbation of CHF who require admission to the hospital directly from the ED | |
| Observational | Patients who present to the ED for acute exacerbation of CHF who are transferred to the Observation Unit from the ED for up to 24 hours. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startSep 2002
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Defined population
- Time perspective
- Other
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Investigators
- Brian C Hiestand, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534066
- Sponsor's protocol ID
- 2002H0262
- Status last verified
- Apr 2007
- First submitted
- 21 Sep 2007
- Last updated
- 24 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Serial BNP Levels as a Predictor of Adverse Outcomes in Emergency Department CHF
- ClinicalTrials.gov ID
- NCT00534066
- Acronym / sponsor ID
- 2002H0262
- Conditions
- Congestive Heart Failure
- Keywords
- Natriuretic Peptide, Brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Sep 2002
- Study completion
- Jun 2006 (actual)
- First posted
- 24 Sep 2007 (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.
The purpose of the study is to determine if a series of BNP blood tests performed on patients who present to the Emergency Department with congestive heart failure (CHF) can predict which patients may have adverse outcomes. If the BNP is shown to be predictive of bad outcomes in certain patients, those patients might receive more intensive therapy early to prevent such outcomes. This was a prospective trial enrolling patients who presented to the ED and were diagnosed with heart failure. Subjects had a blood test for BNP, which is elevated in the presence of heart failure, collected twelve hours after their initial clinical BNP was obtained in the ED. Demographics, history, length of hospital stay, and other approved data were collected. At 30 days and 6 months after discharge, a follow up call was made to determine if the subject had required additional emergency care, had been admitted to a hospital, or had died during that period of time.
Detailed description
BNP is a 32-amino acid peptide secreted almost exclusively by the ventricles under conditions of ventricular wall strain.Multiple studies have examined the utility of BNP as a marker of decompensated heart failure, both in the inpatient and outpatient settings. Several studies have examined the use of a single BNP measure to predict adverse outcomes in CHF patients. Typical study designs have utilized CHF specialty clinics or patients admitted for congestive heart failure (CHF) exacerbation as the study population. Very few studies have utilized BNP in the acute care setting; these studies have also used BNP as a single measure. As the serum half-life of BNP is approximately 22 minutes,BNP levels will respond to measures decreasing ventricular wall strain, such that a decreasing BNP level should be diagnostic of improved CHF. It is our hypothesis that Emergency Department patients with acute CHF exacerbation and a decreasing serum BNP level after 12 hours of therapy will demonstrate an improved outcome when compared to patients whose BNP does not decrease.
Our goal is to establish the utility of serial BNP levels during the intensive initial management of acute CHF. One and six month follow-up patient outcomes will be collected and compared against the serial BNP measurements while the patient was in the acute phase of treatment. It is our hypothesis that serial brain natriuretic peptide (BNP) levels compared at 0 and 12 hours for research purposes will be predictive of a combined endpoint of death, readmission, or repeat Emergency Department visit for recurrent CHF in patients presenting to the Emergency Department with an acute exacerbation of CHF.
To date, no data has been published regarding the utility of serial BNP measurements in the observation unit management of CHF. Our study proposes to compare outcomes in patients managed in the Clinical Decision Unit (CDU), a six bed observation unit in our Emergency Department, against patients admitted for CHF exacerbation. The primary outcome of the study will be the combined endpoint of death, readmission, or repeat Emergency Department visit for recurrent CHF at 30 days and 6 months. For inpatients, and those patients admitted from the CDU to the inpatient service, additional outcome measures will be adverse outcomes (intubation, balloon pump, death, etc) during the index hospitalization. As the clinicians managing the patient will not have access to the 12 hour BNP level, the measurement of BNP itself will not be a source of bias. Our secondary hypothesis is that the occurrence of the combined endpoint will be independent of treatment location (CDU vs inpatient) as opposed to responder vs. non-responder status.
Study design
- Observational model
- Defined population
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Admitted | – | –Patients presenting to the ED with acute exacerbation of CHF who require admission to the hospital directly from the ED |
| Observational | – | –Patients who present to the ED for acute exacerbation of CHF who are transferred to the Observation Unit from the ED for up to 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age18 or older
- primary diagnosis of CHF in the Emergency Department
- admission to the hospital or transfer to the Observation Unit
Key exclusion criteria (4 listed)
- minors, prisoners,pregnant women,unable to provide consent
- unstable angina or acute myocardial infarction in the ED
- dialysis dependent patients
- use of nesiritide as a therapy in the ED
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
Not reported in the source record.
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 24 Sep 2007.
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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.
Brian C Hiestand, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Ohio State University at 1 site in United States.
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 3 inclusion and 4 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 24 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Where can I read the original study information?
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 24 Sep 2007.