Table 2 Adjudicated clinical events in REDHART2 study

Cardiac death (in which a direct cause attributable to cardiac disease is present)

-Sudden cardiac death (in which cardiac death occurred out of the hospital and suddenly; or in the hospital due to ventricular arrhythmias unrelated to other concomitant cardiac conditions)

-Non-cardiac death (in which the event of death is considered not to be a direct consequence of cardiac disease)

Hospitalization for any cause

Hospitalization for heart failure (in which the primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of all 2 conditions listed:

a. Dyspnea or respiratory distress or tachypnea at rest or with minimal exertion;

b. Evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met: pulmonary congestion/edema at physical exam OR chest X-ray; plasma BNP levels ≥ 200 pg/mL; or invasive measurement of left ventricular end-diastolic pressure > 18 mmHg OR pulmonary artery occluding pressure (wedge) > 16 mmHg)

Outpatient worsening of heart failure (defined as the need for intravenous diuretic treatment or need for increase in oral diuretic dose, or new prescription for first or add-on diuretic)

Acute myocardial infarction, as defined by the WHO consensus statement 4th edition

Unstable angina, or need for coronary revascularization

Cardiac tachy-or brady-arrhythmias leading to a new hospitalization or to prolongation of hospital stay

Acute renal failure (defined as an increase in plasma creatinine levels of 50% or 0.5 mg/L)

Acute respiratory failure (not due to heart failure)

Sepsis or other serious infection requiring antibiotic therapy

Acute stroke