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Biomarkers in Acute Heart Failure (BACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00537628
Recruitment Status : Completed
First Posted : October 1, 2007
Last Update Posted : August 1, 2008
Information provided by:
Brahms AG

Brief 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. 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.

Condition or disease
Shortness of Breath Heart Failure

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.

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Study Type : Observational
Actual Enrollment : 1641 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : March 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Emergency Department

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00537628

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United States, California
University of California, San Diego
San Diego, California, United States, 92103
Veterans Affairs Medical Center
San Diego, California, United States, 92161
University of California, San Francisco
San Francisco, California, United States, 94110
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55417
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Virginia
Virgina Commonwealth University
Richmond, Virginia, United States, 23298
Charite- Universitatsmedizin Berlin
Berlin, Germany, 13353
Athens University Hospital Attikon
Athens, Greece
University La Sapienza
Rome, Italy, 00189
New Zealand
University of Otago
Christchurch, New Zealand
Clinical Military Hospital
Wroclaw, Poland, 50-891
University Hospital Basel
Basel, Switzerland, CH-4031
United Kingdom
University of Leicester
Leicester, United Kingdom, LE2 7LX
Sponsors and Collaborators
Brahms AG
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Principal Investigator: Alan S Maisel, MD Veterans Affairs Medical Center, San Diego and University of California, San Diego
Principal Investigator: Stefan D Anker, MD, PhD Universitätsklinikum Charité, Charité - Campus Virchow
Study Chair: Frank Peacock, MD The Cleveland Clinic
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Andreas Bergmann, PhD Chief Research Officer, BRAHMS AG Identifier: NCT00537628    
Other Study ID Numbers: Brahms
First Posted: October 1, 2007    Key Record Dates
Last Update Posted: August 1, 2008
Last Verified: July 2008
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory