Biomarkers in Acute Heart Failure

Heart Failure Clinical Trial

— BACH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537628
• Other study ID #: Brahms
• Status: Completed
• Phase: N/A
• First received: September 28, 2007
• Last updated: July 30, 2008
• Start date: March 2007
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: Brahms AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1641
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyspnea
• Heart Failure
• Shortness of Breath

Locations

Country	Name	City	State
Germany	Charite- Universitatsmedizin Berlin	Berlin
Greece	Athens University Hospital Attikon	Athens
Italy	University La Sapienza	Rome
New Zealand	University of Otago	Christchurch
Poland	Clinical Military Hospital	Wroclaw
Switzerland	University Hospital Basel	Basel
United Kingdom	University of Leicester	Leicester
United States	University of Maryland	Baltimore	Maryland
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Minnesota	Minneapolis	Minnesota
United States	Virgina Commonwealth University	Richmond	Virginia
United States	University of California, San Diego	San Diego	California
United States	Veterans Affairs Medical Center	San Diego	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Brahms AG

Countries where clinical trial is conducted

United States,  Germany,  Greece,  Italy,  New Zealand,  Poland,  Switzerland,  United Kingdom,