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| Name | Class |
|---|---|
| Smerud Medical Research International AS | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piboserod | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Torp-Pedersen, Dr. Med | Bispebjerg Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| Amager Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19567409 | Derived | 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. |
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| 6 months |
| Change in QoL-scores | 6 months |
| Change in 6-minute walk distance | 6 months |
| Copenhagen |
| 2300 |
| Denmark |
| Bispebjerg Hospital | Copenhagen | 2400 | Denmark |
| Frederiksberg Hospital | Frederiksberg | 2000 | Denmark |
| Amtsygehuset i Herlev | Herlev | 2730 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Odense Universitets Hospital | Odense | 5000 | Denmark |
| Svendborg Sygehus | Svendborg | 5700 | Denmark |
| Østlandske Hjertesenter | Moss | 1530 | Norway |
| Fana Hjertesenter | Nesttun | 5221 | Norway |
| Rikshospitalet | Oslo | 0027 | Norway |
| Ullevål Universitetssykehus | Oslo | 0407 | Norway |
| Stavanger Universitetssjukehus | Stavanger | Norway |
| St. Olavs Hospital | Trondheim | 7006 | Norway |
| Castel Hill Hospital | Cottingham | East Yorkshire | HU16 5JQ | United Kingdom |
| Bridlington and District General Hospital | Bridlington | YO16 4QP | United Kingdom |
| Western Infirmary | Glasgow | G11 6NT | United Kingdom |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C479132 | piboserod |
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