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Completed

NCT Number: NCT00421746

A Clinical Study Assessing the Potential of Piboserod for the Treatment of Heart Failure

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Amager Hospital, Copenhagen, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Piboserod

Drug

Primary outcomes

  1. Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging

    Time frame: 6 months

Secondary outcomes

  1. Change in LV systolic and diastolic volume (and/or diameter) by CMR

    Time frame: 6 months

  2. Change in NYHA functional class

    Time frame: 6 months

  3. Change in various biomarkers for heart failure

    Time frame: 6 months

  4. Change in QoL-scores

    Time frame: 6 months

  5. Change in 6-minute walk distance

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Bio-Medisinsk Innovasjon

Industry

Collaborators

  • Smerud Medical Research International AS

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Jan 12, 2007
Registry last updated
Aug 3, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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