Effect of ivabradine versus placebo on cardiac function, exercise capacity, and neuroendocrine activation in patients with Chronic Heart Failure with Preserved left ventricular Ejection FractionAn 8-month, randomised double-blind, placebo controlled, international, multicentre study. - EDIFY

Institut de Recherches Internationales Servier0 个研究点目标入组 400 人开始时间: 2013年2月28日最近更新: 2017年3月13日

适应症

试验速览

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•- Male or female patients,
•- Aged 50 years or older,
•- Symptomatic Chronic Heart Failure of New York Heart Association (NYHA) class II or III for at least 3 months prior to selection,
•- In stable clinical condition with regards to CHF symptoms for at least 4 weeks prior to selection,
•- Documented sinus rhythm and HR superior or equal to 70 bpm on a resting standard 12-lead ECG at selection and inclusion,
•- Left Ventricular Ejection Fraction superior or equal to 45% and E/e’ > 13 (E = early diastolic mitral flow velocity; e’ = mean of mitral annular lateral and septal proto diastolic velocities) or e’ lateral < 10 cm/s and e’ septal < 8 cm/s or LAVI > 34 mL/m² at selection,
•- Documented NT-proBNP = 220 pg/mL or BNP = 80 pg/mL at selection.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•- Recent (less than 3 months) myocardial infarction or coronary revascularisation,
•- Scheduled coronary revascularisation,
•- Severe aortic or mitral stenosis, or severe aortic regurgitation, or severe primary mitral regurgitation,
•- Scheduled surgery for valvular heart disease
•- Congenital heart disease,
•- Previous cardiac transplantation or on list for cardiac transplantation,
•- Documented permanent atrial fibrillation or other cardiac arrhythmia that interfere with the sinus node function, or recent hospitalization for atrial fibrillation or other cardiac arrhythmia that interfere with the sinus node function within the last 3 months,
•- Patients able to walk more than 450 meters within 6 minutes during the selection and the inclusion visits,
•- Previous treatment with ivabradine within the last 6 months before selection or current treatment with ivabradine,
•- large mitral calcifications and previous mitral valvular surgery or intervention.

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