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

Phase 2

Completed

• Conditions: Congestive Heart Failure

• Registration Number: NCT00421746
• Lead Sponsor: Bio-Medisinsk Innovasjon

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-01-11
• Study First Submitted QC: 2007-01-11
• Study First Posted: 2007-01-12
• Study Completion: 2007-07
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-02
• Last Update Posted: 2007-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (17)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Amager Hospital; 🇩🇰 Copenhagen, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Frederiksberg Hospital; 🇩🇰 Frederiksberg, Denmark

Amtsygehuset i Herlev; 🇩🇰 Herlev, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Odense Universitets Hospital; 🇩🇰 Odense, Denmark

Svendborg Sygehus; 🇩🇰 Svendborg, Denmark

Østlandske Hjertesenter; 🇳🇴 Moss, Norway

Fana Hjertesenter; 🇳🇴 Nesttun, Norway

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