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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00537628
Other study ID # Brahms
Secondary ID
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


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, 

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