Heart Failure Clinical Trial
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
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.
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Observational Model: Cohort, Time Perspective: Prospective
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