The addition of cardiac resynchronisation therapy to implantable cardioverter-defibrillator and optimal medical therapy to patients with mild to moderate congestive heart failure symptoms: a randomised controlled trial

niversity of Ottawa Heart Institute (Canada)0 个研究点目标入组 1,800 人开始时间: 2005年11月18日最近更新: 2015年1月13日

适应症

试验速览

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•Amended 06/03/2009:
•Point 2 has been removed: 'Aged greater than or equal to 30, either sex'.
•Initial information at the time of registration:
•1. New York Heart Association (NYHA) class II
•2. Aged greater than or equal to 30 years old, either sex
•3. LVEF less than or equal to 30% by multiple gated acquisition (MUGA) scan or LVEF less than or equal to 30% and LV end diastolic dimension greater than 60 mm (by echocardiogram) within 6 months of randomisation
•4. QRS duration greater than or equal to 120 ms
•5. Optimal heart failure pharmacological therapy
•6. ICD indication for primary or secondary prevention
•7. Normal sinus rhythm OR chronic persistent atrial fibrillation with resting ventricular heart rate less than or equal to 60 bpm and ventricular rate less than or equal to 90 bpm during a 6-minute hall walk. This can be accomplished by pharmacological therapy or catheter AV Junction Ablation.

•1. In hospital patients who have acute cardiac or non-cardiac cause
•2. Intra-venous inotropic agent in the last 4 days
•3. Patients with a life expectancy of less than 1 year non-cardiac cause
•4. Expected to under go cardiac transplantation within 1 year (status I)
•5. Patients with an acute coronary syndrome including myocardial infarction (MI) can be included if the patient has had a previous MI with LV dysfunction (LVEF less than or equal to 30%)
•6. Unable or unwilling to provide informed consent
•7. History of noncompliance of medical therapy
•8. Uncorrected or uncorrectable primary valvular disease
•9. Restrictive, hypertrophic or reversible form of cardiomyopathy
•10. Severe primary pulmonary disease such as cor pulmonale
•11. Tricuspid prosthetic valve
•12. Patients included in other clinical trial that will affect the objectives of this study
•13. Coronary revascularisation (coronary artery bypass graft [CABG] or percutaneous coronary intervention [PCI]) less than 1 month if previously determined LVEF greater than 30%. Patients with a more recent revascularisation can be included if a previous determined LVEF was less than or equal to 30%
•14. Patients with an existing ICD (patients with an existing pacemaker may be included if the patients satisfies all other inclusion/exclusion criteria)

发起方

niversity of Ottawa Heart Institute (Canada)