Clinical trial NCT00421746: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congestive Heart Failure
Lead sponsor: Bio-Medisinsk Innovasjon
Sponsor class: INDUSTRY
Collaborators: name: Smerud Medical Research International AS
First posted: 2007-01-12
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging
timeFrame: 6 months
Secondary outcomes:
measure: Change in LV systolic and diastolic volume (and/or diameter) by CMR
timeFrame: 6 months
measure: Change in NYHA functional class
timeFrame: 6 months
measure: Change in various biomarkers for heart failure
timeFrame: 6 months
measure: Change in QoL-scores
timeFrame: 6 months
measure: Change in 6-minute walk distance
timeFrame: 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Copenhagen
country: Denmark
facility: Amager Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Frederiksberg
country: Denmark
facility: Frederiksberg Hospital
city: Herlev
country: Denmark
facility: Amtsygehuset i Herlev
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Odense
country: Denmark
facility: Odense Universitets Hospital
city: Svendborg
country: Denmark
facility: Svendborg Sygehus
city: Moss
country: Norway
facility: Østlandske Hjertesenter
city: Nesttun
country: Norway
facility: Fana Hjertesenter
city: Oslo
country: Norway
facility: Rikshospitalet
city: Oslo
country: Norway
facility: Ullevål Universitetssykehus
city: Stavanger
country: Norway
facility: Stavanger Universitetssjukehus
city: Trondheim
country: Norway
facility: St. Olavs Hospital
city: Cottingham
country: United Kingdom
facility: Castel Hill Hospital
state: East Yorkshire
city: Bridlington
country: United Kingdom
facility: Bridlington and District General Hospital
city: Glasgow
country: United Kingdom
facility: Western Infirmary
Study officials:
affiliation: Bispebjerg Hospital, Copenhagen, Denmark
name: Christian Torp-Pedersen, Dr. Med
role: STUDY_CHAIR
References:
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.