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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00421746

Enrollment

137

Registered

2007-01-12

Start date

2006-01-31

Completion date

2007-07-31

Last updated

2007-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

Brief summary

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.

Detailed description

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.

Interventions

DRUGPiboserod

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging	6 months

Secondary

Measure	Time frame
Change in LV systolic and diastolic volume (and/or diameter) by CMR	6 months
Change in NYHA functional class	6 months
Change in various biomarkers for heart failure	6 months
Change in QoL-scores	6 months
Change in 6-minute walk distance	6 months

Countries

Denmark, Norway, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026