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
  Purpose

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
Shortness of Breath
Heart Failure

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Brahms AG:

Biospecimen Retention:   Samples Without DNA

plasma


Enrollment: 1641
Study Start Date: March 2007
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Emergency Department

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537628

Locations
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
Germany
Charite- Universitatsmedizin Berlin
Berlin, Germany, 13353
Greece
Athens University Hospital Attikon
Athens, Greece
Italy
University La Sapienza
Rome, Italy, 00189
New Zealand
University of Otago
Christchurch, New Zealand
Poland
Clinical Military Hospital
Wroclaw, Poland, 50-891
Switzerland
University Hospital Basel
Basel, Switzerland, CH-4031
United Kingdom
University of Leicester
Leicester, United Kingdom, LE2 7LX
Sponsors and Collaborators
Brahms AG
Investigators
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
  More Information

No publications provided by Brahms AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Andreas Bergmann, PhD Chief Research Officer, BRAHMS AG
ClinicalTrials.gov Identifier: NCT00537628     History of Changes
Other Study ID Numbers: Brahms
Study First Received: September 28, 2007
Last Updated: July 30, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dyspnea
Heart Failure
Cardiovascular Diseases
Heart Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on October 29, 2014