6. History of hospitalization for HF within 12 months prior to screening or treatment in an out-patient clinic with intravenous therapy (including vasodilators, positive inotropic agents, vasopressors or diuretics) for worsening HF within 12 months prior to screening. Be or must have been diagnosed within the previous 12 months in NYHA class III or IV or INTERMACS class 4, 5, 6 or 7, and at the time of inclusion, must be at least in NYHA class II or greater. If in NYHA class II, 2 or more HF worsening events or NT-ProBNP > 1000 pg/mL requiring hospitalization or outpatient IV therapy during the prior 12 months are required.