A Clinical Study Assessing the Potential of Piboserod for the Treatment of Heart Failure
A Proof of Biological Efficacy Study Assessing the Potential of Piboserod, a Specific 5-HT4 Antagonist, for the Treatment of Symptomatic Congestive Heart Failure on Top of Usual Evidence Based Pharmacological Treatment
The purpose of this study is to determine whether piboserod, a serotonin-4 receptor antagonist, is effective for the treatment of patients with congestive heart failure.
Despite intensive research for decades, mortality and morbidity in chronic heart failure remains quite high. There is an obvious need for new drugs, especially drugs which may have a different mode of action than the existing ones on the market.
The purpose of this trial is to evaluate whether a new drug candidate, piboserod, has beneficial biological effects in stable outpatients with symptomatic heart failure receiving evidence based treatment for heart failure and to assess safety and tolerability of this treatment.
Inclusion Criteria: Clinical diagnosis of CHF (NYHA class II-IV) Locally determined LVEF < 0.35 (by CMR, echocardiography, LV angiography, or radionuclide cardioangiography) Stable sinus rhythm Stable evidence based pharmacological treatment for CHF. Exclusion Criteria: Unstable patients hospitalised within last 2 weeks Baseline prolongation of QTc interval Atrial fibrillation at randomisation MI or re-vascularisation last 3 months Stroke last 3 months.