Heart Failure Clinical Trial
Official title:
Effect of Ivabradine, Carvedilol or Their Combination in Patients With Heart Failure
Patients with heart failure (HF) have a limited exercise tolerance,few pharmacological interventions have been proven effective in improving exercise capacity. At the presence there i conflicting evidence on the effectiveness of beta-blockers on exercise capacity. Ivabradine has been shown to improve prognosis in patients with ischemic heart disease, left ventricular dysfunction and heart rate > 70 bpm. The association of ivabradine and atenolol has been proven effective in increasing exercise tolerance in patients with ischemic heart disease. Aim of the present study is to evaluate the effect of heart rate reduction with ivabradine, carvedilol or their combination in patients with heart failure of ischemic origin.
Patients with chronic heart failure of ischemic origin (120) Stable coronary artery disease
Acute coronary syndromes > 3 months Revascularization procedures > 3 months Naive on heart
rate reducing agents New York Heart Association (NYHA) Class II III 6 minute walking test
(6MW) tolerance between 200 and 400 m Stable medications for the past 3 months
Treatment Ivabradine up to 7.5 mg b.i.d. Carvedilol up to 25 mg b.i.d. Carvedilol and
Ivabradine up to 12.5/5 mg b.i.d.
Efficacy measure Intention to treat Exercise tolerance Quality of life
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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