A Clinical Study Assessing the Potential of Piboserod for the Treatment of Heart Failure
- Conditions
- Congestive Heart Failure
- Registration Number
- NCT00421746
- Lead Sponsor
- Bio-Medisinsk Innovasjon
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 137
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (17)
Fana Hjertesenter
🇳🇴Nesttun, Norway
Ullevål Universitetssykehus
🇳🇴Oslo, Norway
Stavanger Universitetssjukehus
🇳🇴Stavanger, Norway
Rikshospitalet
🇳🇴Oslo, Norway
St. Olavs Hospital
🇳🇴Trondheim, Norway
Svendborg Sygehus
🇩🇰Svendborg, Denmark
Frederiksberg Hospital
🇩🇰Frederiksberg, Denmark
Odense Universitets Hospital
🇩🇰Odense, Denmark
Amager Hospital
🇩🇰Copenhagen, Denmark
Western Infirmary
🇬🇧Glasgow, United Kingdom
Østlandske Hjertesenter
🇳🇴Moss, Norway
Rigshospitalet
🇩🇰Copenhagen, Denmark
Amtsygehuset i Herlev
🇩🇰Herlev, Denmark
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Bridlington and District General Hospital
🇬🇧Bridlington, United Kingdom
Bispebjerg Hospital
🇩🇰Copenhagen, Denmark
Castel Hill Hospital
🇬🇧Cottingham, East Yorkshire, United Kingdom