Trial | NCT00421746  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    piboserod ...

  • Study Participants

    137
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.
Study Started
Jan 31
2006
Study Completion
Jul 31
2007
Last Update
Aug 03
2007
Estimate

Drug Piboserod

Criteria 

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.
No Results Posted