NCT00421746

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_2

Geographic Reach
3 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

August 3, 2007

Status Verified

August 1, 2007

First QC Date

January 11, 2007

Last Update Submit

August 2, 2007

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (5)

  • 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

Interventions

PiboserodDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Amager Hospital

Copenhagen, 2300, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Amtsygehuset i Herlev

Herlev, 2730, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Odense Universitets Hospital

Odense, 5000, Denmark

Location

Svendborg Sygehus

Svendborg, 5700, Denmark

Location

Østlandske Hjertesenter

Moss, 1530, Norway

Location

Fana Hjertesenter

Nesttun, 5221, Norway

Location

Rikshospitalet

Oslo, 0027, Norway

Location

Ullevål Universitetssykehus

Oslo, 0407, Norway

Location

Stavanger Universitetssjukehus

Stavanger, Norway

Location

St. Olavs Hospital

Trondheim, 7006, Norway

Location

Castel Hill Hospital

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

Bridlington and District General Hospital

Bridlington, YO16 4QP, United Kingdom

Location

Western Infirmary

Glasgow, G11 6NT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 19567409DERIVED

Related Links

MeSH Terms

Conditions

Heart Failure

Interventions

piboserod

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Christian Torp-Pedersen, Dr. Med

    Bispebjerg Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 11, 2007

First Posted

January 12, 2007

Study Start

January 1, 2006

Study Completion

July 1, 2007

Last Updated

August 3, 2007

Record last verified: 2007-08

Locations

DK(8)GB(3)NO(6)