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

Congestive Heart Failure Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421746
• Other study ID #: BMI 001 / SMR-1389
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2007
• Last updated: August 2, 2007
• Start date: January 2006
• Est. completion date: July 2007

Study information

• Verified date: August 2007
• Source: Bio-Medisinsk Innovasjon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyDenmark: Danish Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• Piboserod

Locations

Country	Name	City	State
Denmark	Amager Hospital	Copenhagen
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Rigshospitalet	Copenhagen
Denmark	Frederiksberg Hospital	Frederiksberg
Denmark	Amtsygehuset i Herlev	Herlev
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Odense Universitets Hospital	Odense
Denmark	Svendborg Sygehus	Svendborg
Norway	Østlandske Hjertesenter	Moss
Norway	Fana Hjertesenter	Nesttun
Norway	Rikshospitalet	Oslo
Norway	Ullevål Universitetssykehus	Oslo
Norway	Stavanger Universitetssjukehus	Stavanger
Norway	St. Olavs Hospital	Trondheim
United Kingdom	Bridlington and District General Hospital	Bridlington
United Kingdom	Castel Hill Hospital	Cottingham	East Yorkshire
United Kingdom	Western Infirmary	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
Bio-Medisinsk Innovasjon	Smerud Medical Research International AS

Countries where clinical trial is conducted

Denmark,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging		6 months
Secondary	Change in LV systolic and diastolic volume (and/or diameter) by CMR		6 months
Secondary	Change in NYHA functional class		6 months
Secondary	Change in various biomarkers for heart failure		6 months
Secondary	Change in QoL-scores		6 months
Secondary	Change in 6-minute walk distance		6 months

External Links

•   Sponsor's web site