Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study (SHIFT)

Servier

Status and phase: Completed; Phase 3

Conditions: Chronic Heart Failure

Treatments: Drug: Placebo; Drug: Ivabradine

Study type: Interventional

Funder types: Other

Identifiers

NCT02441218

CL3-16257-063

2006-000708-18 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left ventricular ejection fraction and currently receiving recommended therapy for this disease.

Enrollment: 6,505 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic Chronic heart failure (NYHA II, III or IV)
• Left ventricular systolic dysfunction (LVEF ≤ 35%)
• Sinus rhythm and resting heart rate ≥ 70 bpm
• Optimal and unchanged CHF medications or dosages

Exclusion criteria

• Unstable condition within previous 4 weeks
• Myocardial infarction or coronary revascularisation within previous 2 months
• Stroke or transient cerebral ischaemia within previous 4 weeks
• Congenital heart disease
• Severe valvular disease
• Active myocarditis
• Permanent atrial fibrillation or flutter

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6,505 participants in 2 patient groups, including a placebo group

Ivabradine

Experimental group

Treatment:

Drug: Ivabradine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo