Congestive heart failure MedDRA version: 4.0 Level: LLT Classification code 10010684
Conditions
Interventions
Product Name: Piboserod
Product Code: SB-207266
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Sponsors
Bio-Medisinsk Innovasjon AS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females 2. Aged 18 –80 years, both inclusive. 3. Symptomatic, systolic heart failure (NYHA class II-IV), cardiomyopathic or ischemic, for at least 3 months, based on relevant symptoms and locally determined (by cardiac magnetic resonance imaging, echo-cardiography, LV angiography, or radionuclide angiocardiography) systolic left ventricular dysfunction corresponding to LVEF = 0.35 4. Stable sinus rhythm 5. Receiving stable, evidence-based pharmacological treatment for CHF for at least 14 days (if on beta-blockers, for at least 2 months) and with no current plan for changing therapy 6. Ability to conduct regular visits to the clinic 7. Signed informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Unstable patients hospitalised within last 2 weeks, baseline prolongation of QTc interval> 450ms, atrial fibrillation at randomisation, MI or re-vascularisation last 3 months, stroke last 3 months, acute myocarditis or constrictive pericarditis, symptomatic bradycardia or 2nd or 3rd degree AV-block (atrioventricular block), planned major surgery including cardiac revascularisation, symptomatic hypotension or uncontrolled hypertension, clinically significant diseases as specified in protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess biological efficacy of maximum tolerable dose of piboserod on top of evidence based treatments for chronic heart failure (CHF).;Secondary Objective: To assess safety and tolerability of piboserod on top of evidence based treatments for chronic heart failure (CHF).;Primary end point(s): Change in LVEF from baseline to end-of-therapy, as measured using CMR. | — |
Countries
Denmark, United Kingdom
Outcome results
None listed