Chronic heart failure and left ventricular dysfunction MedDRA version: 14.1 Level: PT Classification code 10007558 Term: Cardiac failure chronic System Organ Class: 10007541 - Cardiac disorders MedDRA version: 14.1 Level: PT Classification code 10049694 Term: Left ventricular dysfunction System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients superior or equal to 18 years and less or equal to 80 years. - Symptomatic chronic heart failure for at least 6 months before selection. - NYHA functional class II or III. - Ischemic disease or idiopathic dilated cardiomyopathy as main cause for CHF. - Left ventricular systolic dysfunction as evidenced by a LVEF less or equal to 40 % as measured within 6 months before selection. - ACE inhibitor and/or an ARB treatment for at least 3 months before selection. - NT-proBNP plasma concentration superior or equal to 400 pg/mL or BNP plasma concentration superior or equal to 100 pg/mL. 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 108 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: - Treatment with a beta-blocker within 2 months before selection. - Unstable condition within the previous 4 weeks before selection. - Recent (less than 3 months before selection) myocardial infarction, unstable angina or coronary revascularisation. - History of stroke or cerebral transient ischemic attack within the previous 3 months before selection. - Severe aortic or mitral stenosis, severe aortic regurgitation, or severe mitral regurgitation. - Congenital heart disease. - Hypertrophic obstructive cardiomyopathy. - Pericardial disease. - Atrio-ventricular block of second or third degree. - Corrected QT interval duration (Bazett’s formula) > 480 ms. - Family history of long QT syndrome or congenital long QT syndrome. - Serum creatinine > 200 micromoles/L (> 2.26 mg/dL). - ALAT or ASAT > 3 times the upper limit of normal values. - Serum total calcium 2.6 mmol/L. - Blood hemoglobin lower than 110 g/L (in males) or lower than 100 g/L (in females).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Evaluation of the effects on cardiac function and NT-proBNP.;Secondary Objective: - Evaluation of the safety profile.;Primary end point(s): - Echocardiographic parameters. - NT-proBNP plasma concentrations.;Timepoint(s) of evaluation of this end point: - Echocardiographic parameters at the selection, W000, W004, W008 and W012 visits, - NT-proBNP plasma concentrations before W000 visit, and at W001, W004, W008 and W012 visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Clinical safety measurements (12-lead resting ECG, physical examination, adverse events, blood clinical laboratory parameters);Timepoint(s) of evaluation of this end point: -12-lead resting ECG, physical examination and adverse events at selection, W000, W001, W004, W008, and W012 visits. -blood clinical parameters before W000 visit and at W001, W004, W008 and W012 visits. | — |
Countries
Estonia, Germany, Italy, Latvia, Poland, Portugal, Romania, Russian Federation, Spain, Ukraine, United Kingdom
Contacts
Public ContactClinicla Studies Department
Institut de Recherches Internationales Servier
Outcome results
None listed