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

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Piboserod
Sponsored by
Bio-Medisinsk Innovasjon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Rigshospitalet
  • Amager Hospital
  • Bispebjerg Hospital
  • Frederiksberg Hospital
  • Amtsygehuset i Herlev
  • Hvidovre Hospital
  • Odense Universitets Hospital
  • Svendborg Sygehus
  • Østlandske Hjertesenter
  • Fana Hjertesenter
  • Rikshospitalet
  • Ullevål Universitetssykehus
  • Stavanger Universitetssjukehus
  • St. Olavs Hospital
  • Castel Hill Hospital
  • Bridlington and District General Hospital
  • Western Infirmary

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2007
Last Updated
August 2, 2007
Sponsor
Bio-Medisinsk Innovasjon
Collaborators
Smerud Medical Research International AS
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1. Study Identification

Unique Protocol Identification Number
NCT00421746
Brief Title
A Clinical Study Assessing the Potential of Piboserod for the Treatment of Heart Failure
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bio-Medisinsk Innovasjon
Collaborators
Smerud Medical Research International AS

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Piboserod
Primary Outcome Measure Information:
Title
Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in LV systolic and diastolic volume (and/or diameter) by CMR
Time Frame
6 months
Title
Change in NYHA functional class
Time Frame
6 months
Title
Change in various biomarkers for heart failure
Time Frame
6 months
Title
Change in QoL-scores
Time Frame
6 months
Title
Change in 6-minute walk distance
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Torp-Pedersen, Dr. Med
Organizational Affiliation
Bispebjerg Hospital, Copenhagen, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Amager Hospital
City
Copenhagen
ZIP/Postal Code
2300
Country
Denmark
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Frederiksberg Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Amtsygehuset i Herlev
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Odense Universitets Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Svendborg Sygehus
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Facility Name
Østlandske Hjertesenter
City
Moss
ZIP/Postal Code
1530
Country
Norway
Facility Name
Fana Hjertesenter
City
Nesttun
ZIP/Postal Code
5221
Country
Norway
Facility Name
Rikshospitalet
City
Oslo
ZIP/Postal Code
0027
Country
Norway
Facility Name
Ullevål Universitetssykehus
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Stavanger Universitetssjukehus
City
Stavanger
Country
Norway
Facility Name
St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Castel Hill Hospital
City
Cottingham
State/Province
East Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Bridlington and District General Hospital
City
Bridlington
ZIP/Postal Code
YO16 4QP
Country
United Kingdom
Facility Name
Western Infirmary
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19567409
Citation
Kjekshus JK, Torp-Pedersen C, Gullestad L, Kober L, Edvardsen T, Olsen IC, Sjaastad I, Qvigstad E, Skomedal T, Osnes JB, Levy FO. Effect of piboserod, a 5-HT4 serotonin receptor antagonist, on left ventricular function in patients with symptomatic heart failure. Eur J Heart Fail. 2009 Aug;11(8):771-8. doi: 10.1093/eurjhf/hfp087. Epub 2009 Jun 30.
Results Reference
derived
Links:
URL
http://www.bmioslo.no
Description
Sponsor's web site

Learn more about this trial

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

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