CHAPTER 2.1 34 Supplementary table 1 (continued). Characteristics, inclusion and exclusion criteria of trials Study name BEAUTIFUL CONFIRM-HF FAIR-HF PANTHEON SHIFT Evidence of CAD documented by - previous MI (at least 6 months ago and confirmed by ECG demonstrating abnormal Q waves in 2 contiguous leads and/or biochemical markers of cardiac necrosis) - or previous (at least 6 months ago) percutaneous or surgical coronary revascularisation - or angiographic evidence of at least 50 % narrowing of one or more major coronary vessels In stable condition (for at least 3 months) with regards to angina and/or heart failure symptoms and on appropriate and stable doses, for at least 1 month, of conventional cardiovascular medications. Subjects with stable CHF (NYHA II-III functional class) Brain natriuretic peptide >100 pg/mL and/or Nterminal-pro-brain natriuretic peptide >400 pg/mL at the screening visit. In NYHA II-III functional class due to stable symptomatic chronic heart failure (CHF), and all of the following: a. Two weeks without cardiac hospitalization. b. Patients in NYHA II must have had an acute care admission or emergency room visit for worsening of heart failure within 24 months prior to start of treatment. Diagnosis of chronic heart failure, NYHA class II-IV, One of the following (or both): A) Worsening chronic heart failure requiring hospitalization or an unscheduled outpatient visit in the last 3 months, both requiring initiation or intensification of heart failure therapy and with either: i)BNP ≥ 100 pg/mL or NT-proBNP ≥400 pg/mL (sinus rhythm) or ii) BNP ≥ 300 pg/mL or NT-proBNP ≥1200 pg/mL (atrial fibrillation) AND/OR B) at any time in the past 4 weeks one of: i)BNP ≥ 300 pg/mL or NT-proBNP ≥ 1200 pg/mL (sinus rhythm) ii) BNP ≥ 600 pg/mL or NT-proBNP ≥ 2400 pg/mL (atrial fibrillation) For patients on treatment with angiotensin receptor-neprilysin inhibitors (ARNIs), e.g. Entresto only NT-proBNP Symptomatic CHF i.e., NYHA class II, III or IV for at least 4 weeks prior to selection In stable clinical condition with regards to CHF symptoms for at least 4 weeks prior to selection. All aetiologies of CHF included, except for congenital heart disease and for severe aortic or mitral stenosis, or severe aortic regurgitation or severe primary mitral regurgitation Documented hospital admission for worsening heart failure within 12 months before selection
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