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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 Protocol Code:
CL3-16257-063
Sponsor:
Institut de Recherches Internationales Servier
Clinicaltrials.gov Identifier:
NCT02441218
EudraCT Number:
2006-000708-18
Find a recruiting site
How to participate in this study
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 2 locations
Study description
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.
Results
English (USA)Conditions
Chronic Heart Failure
Interventions / Treatments
The treatment(s) given to the participants in the study.
- Ivabradine
- Placebo
Other study id numbers
Other identification numbers the study may be known by.
- CL3-16257-063
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
18 years and older
(Adult, Older Adult)
Sex
Male/FemaleAccepts Healthy Volunteers
No- * 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
- * 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
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Parallel
A parallel study design compares two or more groups at the same time, with each group receiving a different treatment. Researchers then compare the results to determine which treatment is more effective.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
Ivabradine
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Ivabradine
2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Placebo Comparator:
Placebo
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Placebo
Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.