BACH: Biomarkers in Acute Heart Failure
Study Details
Study Description
Brief Summary
Primary Objectives
-
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.
-
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 | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Diego | San Diego | California | United States | 92103 |
| 2 | Veterans Affairs Medical Center | San Diego | California | United States | 92161 |
| 3 | University of California, San Francisco | San Francisco | California | United States | 94110 |
| 4 | University of Maryland | Baltimore | Maryland | United States | 21201 |
| 5 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
| 6 | University of Minnesota | Minneapolis | Minnesota | United States | 55417 |
| 7 | The Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 8 | Virgina Commonwealth University | Richmond | Virginia | United States | 23298 |
| 9 | Charite- Universitatsmedizin Berlin | Berlin | Germany | 13353 | |
| 10 | Athens University Hospital Attikon | Athens | Greece | ||
| 11 | University La Sapienza | Rome | Italy | 00189 | |
| 12 | University of Otago | Christchurch | New Zealand | ||
| 13 | Clinical Military Hospital | Wroclaw | Poland | 50-891 | |
| 14 | University Hospital Basel | Basel | Switzerland | CH-4031 | |
| 15 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Brahms