Congestive Heart FailureNCT00587938
BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED
An observational study of Congestive Heart Failure, run by Mayo Clinic at 1 site in United States.
Trial summary
Measurement of brain natriuretic peptide (BNP) in dyspneic patients increases diagnostic accuracy for congestive heart failure (CHF). Limited information is available regarding economic outcomes attributable to BNP assay. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congestive Heart Failure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Mar 2005
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Dyspneic patients:65 years or older presenting to the ED with chief complaint of shortness of breath, were enrolled in a randomized, controlled trial.
Who may be able to join
- Dyspneic patients 65 years or older presenting to the ED with chief complaint of shortness of breath.
Who cannot join
- hemodynamically unstability
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Marys Hospital, Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED: A Clinical Development Project
Measurement of brain natriuretic peptide (BNP) in dyspneic patients increases diagnostic accuracy for congestive heart failure (CHF). Limited information is available regarding economic outcomes attributable to BNP assay. The aim of this study was to assess the economic impact of BNP assay in elderly dyspneic patients presenting to the emergency department (ED).
Read the detailed description
Dyspneic patients 65 years were enrolled in a randomized, controlled trial; hemodynamically unstable patients were excluded. BNP (Biosite assay) levels were measured prior to physician assessment with randomization in 1:1 ratio to either BNP 1) level reported or 2) level not reported. ED physicians made triage decisions guided by clinical judgment and nomogram to aid in interpretation of BNP level. Primary outcome was mean total hospital cost per subject. Secondary outcomes included admission rate, service assignment, discharge diagnosis and length of stay. Differences between groups were compared by t-test with bootstrap. Costs reflect 2005 constant dollars.
- Conditions
- Congestive Heart Failure
- Keywords
- congestive heart failure, Brain naturietic peptide, hospital utilization cost
- 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 |
|---|---|---|
| A | BNP level from protocol blood tests initiated in the ED, reported to ED physician prior to ED disposition. | |
| B | BNP level from protocol blood tests initiated in the ED, NOT reported to ED physician prior to ED disposition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean total hospital cost per subject
Measured: spans from ED eval through hospitalization discharge
Secondary outcomes (1)
Included admission rate, service assignment, discharge diagnosis, and length of stay.
Measured: from ED evaluation through hospitalization discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startDec 2003
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Raquel M Schears, MD, MPH, Principal investigator, Mayo ClinicAlfredo L Clavell, MD, Principal investigator, Mayo ClinicLyle J Olsen, MD, Study chair, Mayo ClinicPaula J Santrach, MD, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587938
- Sponsor's protocol ID
- 1780-03
- Status last verified
- Dec 2007
- First submitted
- 26 Dec 2007
- Last updated
- 8 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmidt TA, Salo D, Hughes JA, Abbott JT, Geiderman JM, Johnson CX, McClure KB, McKay MP, Razzak JA, Schears RM, Solomon RC; SAEM Ethics Committee. Confronting the ethical challenges to informed consent in emergency medicine research. Acad Emerg Med. 2004 Oct;11(10):1082-9. doi: 10.1197/j.aem.2004.05.028.
PubMed 15466152Clavell AL, Stingo AJ, Aarhus LL, Burnett JC Jr. Biological actions of brain natriuretic peptide in thoracic inferior vena caval constriction. Am J Physiol. 1993 Dec;265(6 Pt 2):R1416-22. doi: 10.1152/ajpregu.1993.265.6.R1416.
PubMed 8285286
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED: A Clinical Development Project
- ClinicalTrials.gov ID
- NCT00587938
- Acronym / sponsor ID
- 1780-03
- Conditions
- Congestive Heart Failure
- Keywords
- congestive heart failure, Brain naturietic peptide, hospital utilization cost
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 8 Jan 2008 (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.
Measurement of brain natriuretic peptide (BNP) in dyspneic patients increases diagnostic accuracy for congestive heart failure (CHF). Limited information is available regarding economic outcomes attributable to BNP assay. The aim of this study was to assess the economic impact of BNP assay in elderly dyspneic patients presenting to the emergency department (ED).
Detailed description
Dyspneic patients 65 years were enrolled in a randomized, controlled trial; hemodynamically unstable patients were excluded. BNP (Biosite assay) levels were measured prior to physician assessment with randomization in 1:1 ratio to either BNP 1) level reported or 2) level not reported. ED physicians made triage decisions guided by clinical judgment and nomogram to aid in interpretation of BNP level. Primary outcome was mean total hospital cost per subject. Secondary outcomes included admission rate, service assignment, discharge diagnosis and length of stay. Differences between groups were compared by t-test with bootstrap. Costs reflect 2005 constant dollars.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –BNP level from protocol blood tests initiated in the ED, reported to ED physician prior to ED disposition. |
| B | – | –BNP level from protocol blood tests initiated in the ED, NOT reported to ED physician prior to ED disposition. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Dyspneic patients:65 years or older presenting to the ED with chief complaint of shortness of breath, were enrolled in a randomized, controlled trial.
Key inclusion criteria (1 listed)
- Dyspneic patients 65 years or older presenting to the ED with chief complaint of shortness of breath.
Key exclusion criteria (1 listed)
- hemodynamically unstability
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
Mean total hospital cost per subject
Time frame: spans from ED eval through hospitalization discharge
1 secondary outcome
Included admission rate, service assignment, discharge diagnosis, and length of stay.
Time frame: from ED evaluation through hospitalization discharge
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 8 Jan 2008.
- Background: PubMed 15466152Schmidt TA, Salo D, Hughes JA, Abbott JT, Geiderman JM, Johnson CX, McClure KB, McKay MP, Razzak JA, Schears RM, Solomon RC; SAEM Ethics Committee. Confronting the ethical challenges to informed consent in emergency medicine research. Acad Emerg Med. 2004 Oct;11(10):1082-9. doi: 10.1197/j.aem.2004.05.028.
- Background: PubMed 8285286Clavell AL, Stingo AJ, Aarhus LL, Burnett JC Jr. Biological actions of brain natriuretic peptide in thoracic inferior vena caval constriction. Am J Physiol. 1993 Dec;265(6 Pt 2):R1416-22. doi: 10.1152/ajpregu.1993.265.6.R1416.
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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.
Raquel M Schears, MD, MPH principal investigator
Mayo Clinic
Alfredo L Clavell, MD principal investigator
Mayo Clinic
Lyle J Olsen, MD study chair
Mayo Clinic
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 Mayo Clinic 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 1 inclusion and 1 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 8 Jan 2008. 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.
What does the primary outcome measure?
Mean total hospital cost per subject (time frame: spans from ED eval through hospitalization discharge). 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 NCT00587938, which also lists 2 linked publications.
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 8 Jan 2008.