Shortness of BreathBACHNCT00537628
Biomarkers in Acute Heart Failure
An observational study of Shortness of Breath and Heart Failure, run by Brahms AG at 15 sites in 8 countries.
Trial summary
Primary Objectives 1. Mid Region pro Adrenomedullin (MR-proADM) is superior to BNP for the prognosis of heart failure (HF) patients and adds incremental value in predicting outcomes for patients presenting to the Emergency Department (ED) with shortness of breath. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shortness of Breath, Heart Failure
- How many people
- 1,641 participants
- Where
- 15 sitesin 8 countries
- Study dates
- Mar 2007to Jun 2008
- 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: Emergency Department
Who may be able to join
- Eighteen years of age or older.
- The patients must be seen in the urgent care or emergency area with a chief complaint of shortness of breath not due to trauma.
Who cannot join
- Patient is unable to sign or understand the consent form.
- Patient is on any dialysis.
- Patient has trauma related shortness of breath (i.e. penetrating wounds, crush injury).
Trial locations and contacts
15 sites in 8 countries.
15 sites in 8 countries
United States8 sites
University of Maryland
Baltimore, Maryland, 21201
The Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Health System
Detroit, Michigan, 48202
University of Minnesota
Minneapolis, Minnesota, 55417
Virgina Commonwealth University
Richmond, Virginia, 23298
University of California, San Diego
San Diego, California, 92103
Veterans Affairs Medical Center
San Diego, California, 92161
University of California, San Francisco
San Francisco, California, 94110
About this study
Official title: Biomarkers in Acute Heart Failure: An International, Multi-Center Trial Evaluating the Prognostic and Diagnostic Utility of Biomarkers in Patients With Heart Failure Presenting With Shortness of Breath
Primary Objectives
- Mid Region pro Adrenomedullin (MR-proADM) is superior to BNP for the prognosis of heart failure (HF) patients and adds incremental value in predicting outcomes for patients presenting to the Emergency Department (ED) with shortness of breath.
- Mid Region pro A-Type Natriuretic Peptide (MR-proANP) is non-inferior to BNP for the diagnosis of HF in patients presenting to the ED with shortness of breath.
Read the detailed description
The diagnosis of heart failure is often very difficult. Clinical history is often vague, and physical examination findings suffer from lack of specificity and sensitivity. For example, symptoms like shortness of breath and edema are often present in patients without cardiac disease, while elevated jugular venous pressure can be difficult to visualize and auscultation of a third heart sound can be challenging to hear, especially in an emergency room setting.
Although BNP levels can sometimes help clarify the clinical picture when patients present acutely with shortness of breath, patients both with and without heart failure may have BNP values that fall into a "gray zone", where the diagnosis is still very much in question. Also, there can be difficulties in interpreting BNP levels in patients with renal dysfunction, patients with a high body mass index, and patients of advanced age.
Investigative tests in the emergency department such as the electrocardiogram or chest x-ray are also non-specific for diagnosing heart failure. Tests such as echocardiography, while accurate in the assessment of left ventricular dysfunction, are expensive and are not always available on an emergent basis; furthermore, the presence of heart failure with normal systolic function (a.k.a. diastolic dysfunction) can complicate the interpretation of echocardiograms. Additionally, just because a patient has systolic dysfunction on an urgent echocardiogram does not mean that their acute dyspnea is due to heart failure, and so the test itself may not accurately reflect the acute situation at hand.
Another difficult diagnostic dilemma arises when a patient with a history of heart failure presents with signs that could also be consistent an acute respiratory illness such as pneumonia. Often, patients with background heart failure have elevated BNP levels at baseline. In this setting, chest radiographs can be especially difficult to interpret when one must distinguish between edema and infiltrates, or possibly both.
For all of these reasons, there is a pressing need for additional tools to help us differentiate heart failure from other causes of dyspnea in our acutely short of breath patients, and to improve our ability to provide accurate prognostic information and sound therapeutic management to our heart failure patients.
- Conditions
- Shortness of Breath, Heart Failure
- Medical subject headings
- Dyspnea, Heart Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startMar 2007
- Primary completionMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Shortness of BreathStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brahms AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alan S Maisel, MD, Principal investigator, Veterans Affairs Medical Center, San Diego and University of California, San DiegoStefan D Anker, MD, PhD, Principal investigator, Universitätsklinikum Charité, Charité - Campus VirchowFrank Peacock, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537628
- Sponsor's protocol ID
- Brahms
- Acronym
- BACH
- Status last verified
- Jul 2008
- First submitted
- 28 Sep 2007
- Last updated
- 1 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Maisel A, Neath SX, Landsberg J, Mueller C, Nowak RM, Peacock WF, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Clopton P, Filippatos GS, Di Somma S, Anand I, Ng LL, Daniels LB, Christenson RH, Potocki M, McCord J, Terracciano G, Hartmann O, Bergmann A, Morgenthaler NG, Anker SD. Use of procalcitonin for the diagnosis of pneumonia in patients presenting with a chief complaint of dyspnoea: results from the BACH (Biomarkers in Acute Heart Failure) trial. Eur J Heart Fail. 2012 Mar;14(3):278-86. doi: 10.1093/eurjhf/hfr177. Epub 2012 Feb 2.
PubMed 22302662Peacock WF, Nowak R, Christenson R, DiSomma S, Neath SX, Hartmann O, Mueller C, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Filippatos GS, Anand I, Ng LL, Daniels LB, Morgenthaler N, Anker SD, Maisel AS. Short-term mortality risk in emergency department acute heart failure. Acad Emerg Med. 2011 Sep;18(9):947-58. doi: 10.1111/j.1553-2712.2011.01150.x.
PubMed 21906204Maisel A, Mueller C, Nowak RM, Peacock WF, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Clopton P, Filippatos GS, Di Somma S, Anand I, Ng LL, Daniels LB, Neath SX, Christenson R, Potocki M, McCord J, Hartmann O, Morgenthaler NG, Anker SD. Midregion prohormone adrenomedullin and prognosis in patients presenting with acute dyspnea: results from the BACH (Biomarkers in Acute Heart Failure) trial. J Am Coll Cardiol. 2011 Aug 30;58(10):1057-67. doi: 10.1016/j.jacc.2011.06.006.
PubMed 21867843Maisel A, Xue Y, Shah K, Mueller C, Nowak R, Peacock WF, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Clopton P, Filippatos GS, Di Somma S, Anand IS, Ng L, Daniels LB, Neath SX, Christenson R, Potocki M, McCord J, Terracciano G, Kremastinos D, Hartmann O, von Haehling S, Bergmann A, Morgenthaler NG, Anker SD. Increased 90-day mortality in patients with acute heart failure with elevated copeptin: secondary results from the Biomarkers in Acute Heart Failure (BACH) study. Circ Heart Fail. 2011 Sep;4(5):613-20. doi: 10.1161/CIRCHEARTFAILURE.110.960096. Epub 2011 Jul 15.
PubMed 21765124Maisel A, Mueller C, Nowak R, Peacock WF, Landsberg JW, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Clopton P, Filippatos GS, Di Somma S, Anand I, Ng L, Daniels LB, Neath SX, Christenson R, Potocki M, McCord J, Terracciano G, Kremastinos D, Hartmann O, von Haehling S, Bergmann A, Morgenthaler NG, Anker SD. Mid-region pro-hormone markers for diagnosis and prognosis in acute dyspnea: results from the BACH (Biomarkers in Acute Heart Failure) trial. J Am Coll Cardiol. 2010 May 11;55(19):2062-76. doi: 10.1016/j.jacc.2010.02.025.
PubMed 20447528
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Acute Heart Failure: An International, Multi-Center Trial Evaluating the Prognostic and Diagnostic Utility of Biomarkers in Patients With Heart Failure Presenting With Shortness of Breath
- ClinicalTrials.gov ID
- NCT00537628
- Acronym / sponsor ID
- BACH / Brahms
- Conditions
- Shortness of Breath, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,641 participants (actual)
- Lead sponsor
- Brahms AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 1 Oct 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.
Primary Objectives
- Mid Region pro Adrenomedullin (MR-proADM) is superior to BNP for the prognosis of heart failure (HF) patients and adds incremental value in predicting outcomes for patients presenting to the Emergency Department (ED) with shortness of breath.
- Mid Region pro A-Type Natriuretic Peptide (MR-proANP) is non-inferior to BNP for the diagnosis of HF in patients presenting to the ED with shortness of breath.
Detailed description
The diagnosis of heart failure is often very difficult. Clinical history is often vague, and physical examination findings suffer from lack of specificity and sensitivity. For example, symptoms like shortness of breath and edema are often present in patients without cardiac disease, while elevated jugular venous pressure can be difficult to visualize and auscultation of a third heart sound can be challenging to hear, especially in an emergency room setting.
Although BNP levels can sometimes help clarify the clinical picture when patients present acutely with shortness of breath, patients both with and without heart failure may have BNP values that fall into a "gray zone", where the diagnosis is still very much in question. Also, there can be difficulties in interpreting BNP levels in patients with renal dysfunction, patients with a high body mass index, and patients of advanced age.
Investigative tests in the emergency department such as the electrocardiogram or chest x-ray are also non-specific for diagnosing heart failure. Tests such as echocardiography, while accurate in the assessment of left ventricular dysfunction, are expensive and are not always available on an emergent basis; furthermore, the presence of heart failure with normal systolic function (a.k.a. diastolic dysfunction) can complicate the interpretation of echocardiograms. Additionally, just because a patient has systolic dysfunction on an urgent echocardiogram does not mean that their acute dyspnea is due to heart failure, and so the test itself may not accurately reflect the acute situation at hand.
Another difficult diagnostic dilemma arises when a patient with a history of heart failure presents with signs that could also be consistent an acute respiratory illness such as pneumonia. Often, patients with background heart failure have elevated BNP levels at baseline. In this setting, chest radiographs can be especially difficult to interpret when one must distinguish between edema and infiltrates, or possibly both.
For all of these reasons, there is a pressing need for additional tools to help us differentiate heart failure from other causes of dyspnea in our acutely short of breath patients, and to improve our ability to provide accurate prognostic information and sound therapeutic management to our heart failure patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency Department
Key inclusion criteria (2 listed)
- Eighteen years of age or older.
- The patients must be seen in the urgent care or emergency area with a chief complaint of shortness of breath not due to trauma.
Key exclusion criteria (3 listed)
- Patient is unable to sign or understand the consent form.
- Patient is on any dialysis.
- Patient has trauma related shortness of breath (i.e. penetrating wounds, crush injury).
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 1 Aug 2008.
- Derived from this study: PubMed 22302662Maisel A, Neath SX, Landsberg J, Mueller C, Nowak RM, Peacock WF, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Clopton P, Filippatos GS, Di Somma S, Anand I, Ng LL, Daniels LB, Christenson RH, Potocki M, McCord J, Terracciano G, Hartmann O, Bergmann A, Morgenthaler NG, Anker SD. Use of procalcitonin for the diagnosis of pneumonia in patients presenting with a chief complaint of dyspnoea: results from the BACH (Biomarkers in Acute Heart Failure) trial. Eur J Heart Fail. 2012 Mar;14(3):278-86. doi: 10.1093/eurjhf/hfr177. Epub 2012 Feb 2.
- Derived from this study: PubMed 21906204Peacock WF, Nowak R, Christenson R, DiSomma S, Neath SX, Hartmann O, Mueller C, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Filippatos GS, Anand I, Ng LL, Daniels LB, Morgenthaler N, Anker SD, Maisel AS. Short-term mortality risk in emergency department acute heart failure. Acad Emerg Med. 2011 Sep;18(9):947-58. doi: 10.1111/j.1553-2712.2011.01150.x.
- Derived from this study: PubMed 21867843Maisel A, Mueller C, Nowak RM, Peacock WF, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Clopton P, Filippatos GS, Di Somma S, Anand I, Ng LL, Daniels LB, Neath SX, Christenson R, Potocki M, McCord J, Hartmann O, Morgenthaler NG, Anker SD. Midregion prohormone adrenomedullin and prognosis in patients presenting with acute dyspnea: results from the BACH (Biomarkers in Acute Heart Failure) trial. J Am Coll Cardiol. 2011 Aug 30;58(10):1057-67. doi: 10.1016/j.jacc.2011.06.006.
- Derived from this study: PubMed 21765124Maisel A, Xue Y, Shah K, Mueller C, Nowak R, Peacock WF, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Clopton P, Filippatos GS, Di Somma S, Anand IS, Ng L, Daniels LB, Neath SX, Christenson R, Potocki M, McCord J, Terracciano G, Kremastinos D, Hartmann O, von Haehling S, Bergmann A, Morgenthaler NG, Anker SD. Increased 90-day mortality in patients with acute heart failure with elevated copeptin: secondary results from the Biomarkers in Acute Heart Failure (BACH) study. Circ Heart Fail. 2011 Sep;4(5):613-20. doi: 10.1161/CIRCHEARTFAILURE.110.960096. Epub 2011 Jul 15.
- Derived from this study: PubMed 20447528Maisel A, Mueller C, Nowak R, Peacock WF, Landsberg JW, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Clopton P, Filippatos GS, Di Somma S, Anand I, Ng L, Daniels LB, Neath SX, Christenson R, Potocki M, McCord J, Terracciano G, Kremastinos D, Hartmann O, von Haehling S, Bergmann A, Morgenthaler NG, Anker SD. Mid-region pro-hormone markers for diagnosis and prognosis in acute dyspnea: results from the BACH (Biomarkers in Acute Heart Failure) trial. J Am Coll Cardiol. 2010 May 11;55(19):2062-76. doi: 10.1016/j.jacc.2010.02.025.
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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.
Alan S Maisel, MD principal investigator
Veterans Affairs Medical Center, San Diego and University of California, San Diego
Stefan D Anker, MD, PhD principal investigator
Universitätsklinikum Charité, Charité - Campus Virchow
Frank Peacock, MD study chair
The Cleveland Clinic
15 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shortness of Breath and Heart Failure, run by Brahms AG at 15 sites in 8 countries.
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 3 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 1 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany, Greece, Italy, New Zealand and 3 more countries. 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?
On the ClinicalTrials.gov record for NCT00537628, which also lists 5 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 1 Aug 2008.