A Proof of Biological Efficacy Study Assessing the Potential of Piboserod a Specific 5-HT4 Antagonist for the Treatment of Symptomatic Congestive Heart Failure in stable outpatients NYHA class II-III on top of Usual Evidence Based Pharmacological treatment

Conditions: Congestive heart failure
MedDRA version: 4.0Level: LLTClassification code 10010684

Registration Number: EUCTR2005-004487-22-DK

Lead Sponsor: Bio-Medisinsk Innovasjon AS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 156

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>

Secondary Outcome Measures