NCT01178528

Heart Rate Reduction in Heart Failure

Effect of Ivabradine, Carvedilol or Their Combination in Patients With Heart Failure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	ivabradine	7.5 mg bd
DRUG	"Drug:Carvedilol" and "Drug:Ivabradine"	up to 12.5/5 mg bd
DRUG	Carvedilol	25 mg bd

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-06-01
• Completion: 2010-10-01
• First posted: 2010-08-10
• Last updated: 2014-09-30
• Results posted: 2014-09-30

Locations

2 sites across 1 country: Italy