Evaluation of the effects of 4 oral dosages of S 44121 in patients with chronic heart failure and left ventricular dysfunction not treated with a beta-blocker.
- Conditions
- Chronic heart failure and left ventricular dysfunctionMedDRA version: 14.1Level: PTClassification code 10007558Term: Cardiac failure chronicSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 14.1Level: PTClassification code 10049694Term: Left ventricular dysfunctionSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2009-011559-38-EE
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 125
- 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
- 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 < 2.1 mmol/L or > 2.6 mmol/L.
- Blood hemoglobin lower than 110 g/L (in males) or lower than 100 g/L (in females).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>- NT-proBNP plasma concentrations.;Timepoint(s) of evaluation of this end point: - Echocardiographic parameters at the selection, W000, W004, W008 and W012 visits,<br>- NT-proBNP plasma concentrations before W000 visit, and at W001, W004, W008 and W012 visits.
- Secondary Outcome Measures
Name Time Method 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.<br>-blood clinical parameters before W000 visit and at W001, W004, W008 and W012 visits.