Heart failure with preserved left ventricular ejection fraction MedDRA version: 17.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849
Conditions
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of ivabradine compared to placebo on the diastolic function, the exercise capacity and the neuroendocrine activation over an 8-month treatment period.;Secondary Objective: - To evaluate the effects of ivabradine compared to placebo on cardiac function and structural parameters, quality of life, NYHA classification and other biomarkers; - To evaluate the safety and tolerance profile of ivabradine compared to placebo. ;Primary end point(s): Co-primary endpoints based on echocardiography (E/e'), neuroendocrine activation (NT-proBNP) and six-minute walk test ;Timepoint(s) of evaluation of this end point: Co-primary endpoints measured up to M008 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy and safety endpoints ;Timepoint(s) of evaluation of this end point: All over the study | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Czech Republic, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Portugal, Russian Federation, Slovenia, Spain, Taiwan, United Kingdom
Contacts
Public ContactClinical Studies Department
Institut de Recherches Internationales Servier
Outcome results
None listed