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

August 2, 2007 updated by: Bio-Medisinsk Innovasjon

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

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.

Study Overview

Status

Completed

Conditions

Congestive Heart Failure

Intervention / Treatment

Drug: Piboserod

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 Type

Interventional

Enrollment (Actual)

137

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Copenhagen, Denmark, 2100
    - Rigshospitalet
  - Copenhagen, Denmark, 2300
    - Amager Hospital
  - Copenhagen, Denmark, 2400
    - Bispebjerg Hospital
  - Frederiksberg, Denmark, 2000
    - Frederiksberg Hospital
  - Herlev, Denmark, 2730
    - Amtsygehuset i Herlev
  - Hvidovre, Denmark, 2650
    - Hvidovre Hospital
  - Odense, Denmark, 5000
    - Odense Universitets Hospital
  - Svendborg, Denmark, 5700
    - Svendborg Sygehus
Norway
- - Moss, Norway, 1530
    - Østlandske Hjertesenter
  - Nesttun, Norway, 5221
    - Fana Hjertesenter
  - Oslo, Norway, 0027
    - Rikshospitalet
  - Oslo, Norway, 0407
    - Ulleval Universitetssykehus
  - Stavanger, Norway
    - Stavanger Universitetssjukehus
  - Trondheim, Norway, 7006
    - St. Olavs Hospital
United Kingdom
- - Bridlington, United Kingdom, YO16 4QP
    - Bridlington and District General Hospital
  - Glasgow, United Kingdom, G11 6NT
    - Western Infirmary
- East Yorkshire
  - Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
    - Castel Hill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bio-Medisinsk Innovasjon

Collaborators

Smerud Medical Research International AS

Investigators

Study Chair: Christian Torp-Pedersen, Dr. Med, Bispebjerg Hospital, Copenhagen, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

Sponsor's web site

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

January 11, 2007

First Submitted That Met QC Criteria