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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
137
Rigshospitalet
Copenhagen, Denmark
Amager Hospital
Copenhagen, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging
Time frame: 6 months
Change in LV systolic and diastolic volume (and/or diameter) by CMR
Time frame: 6 months
Change in NYHA functional class
Time frame: 6 months
Change in various biomarkers for heart failure
Time frame: 6 months
Change in QoL-scores
Time frame: 6 months
Change in 6-minute walk distance
Time frame: 6 months
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Frederiksberg Hospital
Frederiksberg, Denmark
Amtsygehuset i Herlev
Herlev, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Odense Universitets Hospital
Odense, Denmark
Svendborg Sygehus
Svendborg, Denmark
Østlandske Hjertesenter
Moss, Norway
Fana Hjertesenter
Nesttun, Norway
...and 7 more locations