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Biomarkers in Acute Heart Failure (BACH)

This study has been completed.
Sponsor:
Information provided by:
Brahms AG
ClinicalTrials.gov Identifier:
NCT00537628
First received: September 28, 2007
Last updated: July 30, 2008
Last verified: July 2008

September 28, 2007
July 30, 2008
March 2007
May 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00537628 on ClinicalTrials.gov Archive Site
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Biomarkers in Acute Heart Failure
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

  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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

plasma

Non-Probability Sample

Emergency Department

  • Shortness of Breath
  • Heart Failure
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1641
June 2008
May 2008   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Greece,   Italy,   New Zealand,   Poland,   Switzerland,   United Kingdom
 
NCT00537628
Brahms
No
Andreas Bergmann, PhD Chief Research Officer, BRAHMS AG
Brahms AG
Not Provided
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
Brahms AG
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP