Eplerenone in Heart Failure Treatment
Condition: Heart Failure; Acute Myocardial Infarction; Hypertension
MeSH terms: Heart Failure; Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Beta-blockers should be administered to all patients with heart failure stage II to IV
      according to NYHA.Beta-blockers reduce mortality and hospitalizations and improve the
      operational phase for all categories of patients with heart failure. Since beta-blockers,
      only carvedilol, metoprolol, bisoprolol and recently nevimpololi have shown these benefits
      and so, only they have evidence to be provided.

      Eplerenone is indicated, in addition to conventional therapy, for reducing the risk of
      cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction
      (LVEF ≤ 40%) and clinically proven heart failure after recent myocardial infarction.
    

Detailed description: 
      Heart Failure (HF) As heart failure is defined as a complex clinical syndrome that can result
      from any structural or functional cardiac disorder and affects the ability of the ventricle
      to accept or eject blood. Its incidence is increasing in recent years in the Western world.
      It is estimated that 6% - 10% of the population over 65 suffers from heart failure. The
      clinical picture of heart failure is shortness of breath, fatigue tolerance restriction and
      fluid retention that can lead to pulmonary congestion or peripheral edema. These symptoms and
      signs are not required to appear all at once in each patient. Some patients simply have a
      reduced exercise tolerance, while others dominate the swelling and do not report dyspnea or
      fatigue. For the diagnosis of heart failure is necessary apart from the existence of symptoms
      objective confirmation cardiac dysfunction, preferably by echocardiography, or more
      specialized and less available methods, such as magnetic resonance imaging heart and
      radionuclide ventriculography.

      Coronary heart disease is nowadays the dominant cause of heart failure, as 65-70% of patients
      with heart failure suffer from coronary disease. The cardiomyopathies and especially dilated,
      is the cause of heart failure in 20% of cases. The myocarditis, hyperthyroidism and abuse of
      ethanol, are responsible for a significant number of patients with type distending heart
      failure. Hypertension and valvular dominated in the past, occupy small percentage today as
      heart failure causes. The heart failure can be divided into right or left, depending on
      whether the predominant symptoms resulting from congestion of systemic or pulmonary veins,
      respectively. Moreover, heart failure is separated into systolic or diastolic depending on
      whether systolic or diastolic performance of the left ventricle is affected. In most patients
      with systolic heart failure and diastolic dysfunction coexist. However, in 30% of patients
      with heart failure is pure diastolic dysfunction.

      For the diagnosis of heart failure with diastolic dysfunction criteria require:

        1. In the presence of signs and symptoms of heart failure

        2. ejection fraction of the left ventricle> 45%

        3. the presence of one of three types of abnormal left ventricular filling during diastole
           (relaxation extension, restrictive type).

      There are four operating stages depending on the symptoms of patients with heart failure,
      according to the classification in NYHA (New York Heart Association). At the operational
      stage I patients have symptoms of heart failure at a high level of exercise, beyond the
      ordinary. In stage II, the symptoms appear in a regular exercise level at stage III in small
      fatigue, while in stage IV symptoms occur at rest, so that patients are unable to look after
      themselves. Medication and diet can alter the operating phase which is the patient, without
      any significant change occurs in ventricular performance. It is particularly interesting that
      there is little correlation between symptoms and systolic left ventricular performance as
      expressed by the ejection fraction. Thus, patients with low ejection fraction <25% can be
      virtually asymptomatic, while others slightly influenced ejection fraction have serious
      discomfort. Changes of abdominal diatasimotitas of pericardial voltage, any valvular
      deficiencies and especially the function of the right ventricle are those factors which
      together with systolic left ventricular performance determine the occurrence or not of the
      symptoms of heart failure patients. In heart failure the function of the left ventricle is
      gradually worsening even in the absence of new effect damaging agent. This is the famous
      remodeling (Cardiac Remodeling) of the left ventricle, during which the investigators
      dilatation, hypertrophy and more spherical the shape. Thus, the mechanical performance of the
      ventricle decreases, increasing the mitral insufficiency due to distension of the mitral
      annulus, and increases the parietal stress. Ventricular remodeling contribute to continuous
      deterioration of symptoms, despite any treatment. The activation of the neurohormonal system
      proved to be the most important factor in why the cardiac remodeling and the unfavorable
      development of heart failure. Patients with heart failure have in their plasma levels of
      noradrenaline, angiotensin II, aldosterone, endothelin and cytokines which may act
      deleteriously on the structure and functioning of the heart. The mobilization of
      neurohormonal mechanisms in heart failure causes fluid retention and sodium, peripheral
      vasoconstriction, myocardial fibrosis and toxic effect on myocardial cells, creating a
      vicious cycle of deteriorating architecture and performance of the failing heart.

      Ejection Fraction

      The relation between stroke volume, which is extruded from the left ventricle and the
      starting end diastole filling volume gives a measure of the contractile function of the left
      ventricle. Each patient with known cardiovascular disease should be subject to assessment of
      left ventricular function by measuring ejection fraction. Several studies have demonstrated
      that when the ejection fraction (LVEF), which measures the ability of the heart to eject
      blood into the aorta, not exceed 40% (natural rate ^ 50%) increased dramatically
      postinfarction mortality. The ejection fraction is a reliable prognostic indicator can be
      calculated by ultrasonography. The reduced ejection fraction is associated with an increased
      risk of life-threatening arrhythmias, heart failure and death. A low ejection fraction,
      particularly after myocardial infarction, is a strong indication for the administration of
      beta-blockers, as many studies have shown that administration of these drugs significantly
      reduces cardiovascular mortality.

      Rationale of the study

      This study intends to recruit within 6 months of clinical practice in the Greek reality
      regarding the data administration of eplerenone in addition to standard therapy including
      beta-blockers, to reduce the risk of cardiovascular mortality and morbidity in stable
      patients with dysfunction left ventricle (LVEF ≤ 40%) and clinically proven heart failure
      after recent myocardial infarction.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Heart Failure