Effect of ivabradine versus placebo on cardiac function, exercise capacity, and neuroendocrine activation in patients with Chronic Heart Failure with Preserved left ventricular Ejection Fraction;An 8-month, randomised double-blind, placebo controlled, international, multicentre study.
- Conditions
- diastolic heartfailureheartfailure with preserved ejectionfraction10019280
- Registration Number
- NL-OMON41325
- Lead Sponsor
- Institut de Recherches Internationales Servier I.R.I.S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
- 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 50% and E/e* >= 13 (E = early diastolic mitral flow velocity; e* = mean of mitral annular lateral and septal proto diastolic velocities) or e* lateral >= 10 cm/s and e* septal >= 8 cm/s or LAVI >= ; 34 mL/m² at selection,;- Documented NT-proBNP >= ; 300 pg/mL or BNP >= ; 100 pg/mL at selection.
-Ability to perform the 6' walk test
- 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 or current treatment with ivabradine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints of the study are the following:<br /><br>the ratio E/e*, measured on echocardiography,<br /><br>the 6-minute walk test,<br /><br>NT-proBNP plasma level.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives are:<br /><br>-to evaluate the effects of ivabradine compared to placebo on:<br /><br>• cardiac function and structural parameters,<br /><br>• quality of life,<br /><br>• NYHA classification,<br /><br>• other biomarkers (including optional microRNA),<br /><br>-and to evaluate the safety and tolerance profile of ivabradine compared to<br /><br>placebo.</p><br>