EUCTR2013-003000-39-LVActive, not recruitingNot Applicable
Evaluation of the pharmacodynamics, pharmacokinetics andsafety of repeated escalating oral doses of S 38844 versus placeboin patients with chronic heart failure and left ventricular systolicdysfunctionA phase II, randomised, double-blind, parallel-group, placebocontrolled, international multicentre study
Institut de Recherches Internationales Servier0 sites200 target enrollmentStarted: September 11, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Documented sinus rhythm and mean HR = 75 bpm measured on two consecutive resting 12-leads ECGs recordings one minute registration - performed at least 5 minutes apart (supine position for at least 10 minutes rest). If one of the two HR measurements is 73 or 74 bpm at the inclusion visit, the patient can be included provided that the mean of both HR measurements at the visit is = 75 bpm,
- •- LVEF = 35% as measured and documented within the previous 6 months (in stable clinical condition). For patient without known diagnosis of LVEF = 35%, a LVEF will be scheduled before inclusion visit,
- •- Compliant to study treatment during run-in period (70-130%),
- •- Symptomatic CHF of New York Heart Association (NYHA) class II, III or IV 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,
- •- With optimal and unchanged CHF medications or dosages, for at least 4 weeks prior to 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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
Exclusion Criteria
- •- LVEF of 35% or higher on a recently performed measurement (less than 6 months),
- •- Serum haemoglobin < 110 g/L,
- •- ALT or AST > 3 times the upper limit of normal values,
- •- Significant change in cardiovascular condition, since the informed consent signature, change in heart failure background therapy or dosage, or use of intravenous inotropic therapies,
- •- Recent (less than 3 months) myocardial infarction or coronary revascularization,
- •- Scheduled coronary revascularization,
- •- Severe aortic or mitral stenosis, or severe aortic regurgitation, or severe primary mitral regurgitation,
- •- Scheduled surgery for valvular heart disease,
- •- Cardiac Resynchronisation Therapy (CRT),
- •- Pacemaker carrier,
- •- 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
- •- Positive blood and/or urinary pregnancy test
Investigators
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