Proefschrift

CHAPTER 2.1 38 Supplementary table 1 (continued). Characteristics, inclusion and exclusion criteria of trials Study name BEAUTIFUL CONFIRM-HF FAIR-HF PANTHEON SHIFT Exclusion criteria Unstable cardiovascular condition History of stroke or cerebral transient ischaemic attack within the preceding 3 months Valvular disease likely to require surgery within the next 3 years Current severe symptoms of heart failure (NYHA class IV) Patient with recent (less than 6 months) MI or coronary revascularisation Patient scheduled for revascularisation (PCI or CABG)Implanted pacemaker or implantable cardioverter defibrillator Sick sinus syndrome, sinoatrial block, congenital long QT, complete atrio-ventricular blockadePatient with transplanted heart Unstable angina pectoris as judged by the investigator; Severe valvular or left ventricular outflow obstruction disease needing intervention Atrial fibrillation/flutter with a mean ventricular response rate at rest >100 beats per minute. Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months prior to randomization Coronary-artery bypass graft, percutaneous intervention or major surgery, including thoracic and cardiac surgery, within the last 3 months. Unstable angina pectoris as judged by the investigator, Clinically significant uncorrected valvular disease or left ventricular outflow obstruction Obstructive cardiomyopathy Poorly controlled fast atrial fibrillation or flutter Poorly controlled symptomatic brady- or tachyarrhythmias. Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months. Coronary-artery bypass graft, percutaneous intervention or major surgery, including thoracic and cardiac surgery, within the last 3 months. Occurrence of any of the following within 3 months prior to randomization:- Myocardial infarction- Hospitalization for unstable angina- Stroke or transient ischemic attackCoronary artery bypass graft (CABG) Percutaneous coronary intervention (PCI)- Implantation of a cardiac resynchronization therapy device (CRTD) Carotid angioplastyPCI, CABG or implantation of a CRTD planned between randomizationand end of study Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic dilated cardiomyopathy Acute de-novo heart failure Known clinically significant persistent coronary ischemia based on medical history, preexisting or current exercise testing Unstable condition within the previous 4 weeks History of stroke or transient cerebral ischaemia within the previous 4 weeks. Severe aortic or mitral stenosis, or severe aortic regurgitation or severe primary mitral regurgitation Scheduled surgery for valvular heart disease Active myocarditis Congenital heart diseases Significant cardiovascular condition, including the occurrence of a pre-specified event since the informed consent signature, change in heart failure background therapy or dosage, or use of intravenous inotropic therapies Recent (less than 2 months) myocardial or coronary revascularisation Scheduled coronary revascularisation (PCI or CABG)

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