Heart Failure Clinical Trial
— SISTOLAOfficial title:
Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France
| Verified date | July 2010 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Haute Autorité de Santé Transparency Commission |
| Study type | Observational |
The purpose of this study is to describe the way candesartan is used in heart failure treatment in France (treatment initiation and monitoring), treatment stops occurrence and reasons for and patients clinical evolution
| Status | Completed |
| Enrollment | 450 |
| Est. completion date | July 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - outpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure Exclusion Criteria: - patients included in a clinical trial the last 30 days before consultation - patients unable to answer the questions for linguistic or cognitive reasons - patients who will be difficult to follow during the one year study |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Research Site | Allauch Cedex | Provence |
| France | Research Site | Amiens Cedex 3 | Picardie |
| France | Research Site | Annecy Le Vieux | Dauphine |
| France | Research Site | Annemasse | Dauphine |
| France | Research Site | APT | Vallee Du Rhone |
| France | Research Site | Arles | Languedoc |
| France | Research Site | Arpajon | Touraine |
| France | Research Site | Arras Cedex | Artois |
| France | Research Site | Aulnay Sous Bois | Paris Nord Est |
| France | Research Site | Beauchamp | Vexin |
| France | Research Site | Beauvais Cedex | Vexin |
| France | Research Site | Besancon Cedex | Aube Franche Comte |
| France | Research Site | Bethune | Artois |
| France | Research Site | Beziers | Catalogne |
| France | Research Site | Beziers Cedex | Catalogne |
| France | Research Site | Bordeaux | Aquitaine Nord |
| France | Research Site | Boulogne Billancourt Cedex | Hauts de Seine |
| France | Research Site | Bourgoin Jallieu | Lyonnais |
| France | Research Site | Bron Cedex | Lyonnais |
| France | Research Site | Bry Sur Marne Cedex | Brie |
| France | Research Site | Caen Cedex 1 | Basse Normandie |
| France | Research Site | Caen Cedex 4 | Basse Normandie |
| France | Research Site | Castanet Tolosan | Midi Pyrenees |
| France | Research Site | Castelsarrasin | Gascogne |
| France | Research Site | Cergy | Vexin |
| France | Research Site | Chambray Les Tours Cedex | Touraine |
| France | Research Site | Chateau D Olonne | Charente |
| France | Research Site | Chateaubriant | Pays de Loire |
| France | Research Site | Chateaurenard | Vallee Du Rhone |
| France | Research Site | Chelles | Vexin |
| France | Research Site | Clermont Ferrand | Auvergne Stephanois |
| France | Research Site | Cogolin | Maures Corse |
| France | Research Site | Conde Sur L Escaut | Picardie |
| France | Research Site | Creil Cedex 1 | Vexin |
| France | Research Site | Dax Cedex | Aquitaine Sud |
| France | Research Site | Dijon | Bourgogne |
| France | Research Site | Dole Cedex | Bourgogne |
| France | Research Site | Epernay | Champagne Ardennes |
| France | Research Site | Evecquemont | Yvelines |
| France | Research Site | Gap Cedex | Vallee Du Rhone |
| France | Research Site | Gennevilliers | Yvelines |
| France | Research Site | Gleize | Lyonnais |
| France | Research Site | Granville Cedex | Basse Normandie |
| France | Research Site | Hazebrouck | Flandres |
| France | Research Site | Hyeres | Maures Corse |
| France | Research Site | La Source | Sologne |
| France | Research Site | Langres Cedex | Aube Franche Comte |
| France | Research Site | Lannion Cedex | Bretagne Nord |
| France | Research Site | Lille Cedex | Flandres |
| France | Research Site | Limoges | Limousin |
| France | Research Site | Lyon Cedex 03 | Lyonnais |
| France | Research Site | Maisons Laffitte | Yvelines |
| France | Research Site | Marseille | Provence |
| France | Research Site | Mayenne Cedex | Basse Normandie |
| France | Research Site | Meaux | Brie |
| France | Research Site | Meaux Cedex | Brie |
| France | Research Site | Montargis | Sologne |
| France | Research Site | Montauban | Gascogne |
| France | Research Site | Montfermeil | Paris Nord Est |
| France | Research Site | Montpellier | Languedoc |
| France | Research Site | Montreuil | Paris Nord Est |
| France | Research Site | Montreuil Cedex | Paris Nord Est |
| France | Research Site | Morlaix Cedex | Bretagne Sud |
| France | Research Site | Mulhouse Cedex 1 | Alsace |
| France | Research Site | Muret Cedex | Midi Pyrenees |
| France | Research Site | Nancy | Lorraine |
| France | Research Site | Nantes | Pays de Loire |
| France | Research Site | Nice | Esterel |
| France | Research Site | Nimes | Languedoc |
| France | Research Site | Niort | Charente |
| France | Research Site | Orleans | Sologne |
| France | Research Site | Paray Le Monial Cedex | Bourgogne |
| France | Research Site | Paris | Paris Centre |
| France | Research Site | Paris Cedex 04 | Paris Centre |
| France | Research Site | Paris Cedex 15 | Paris Centre |
| France | Research Site | Perigueux | Gascogne |
| France | Research Site | Perigueux Cedex | Gascogne |
| France | Research Site | Perpignan | Catalogne |
| France | Research Site | Poitiers Cedex | Charente |
| France | Research Site | Pontoise | Vexin |
| France | Research Site | Rennes | Bretagne Nord |
| France | Research Site | Rillieux La Pape Cedex | Lyonnais |
| France | Research Site | Rodez | Languedoc |
| France | Research Site | Rognac | Provence |
| France | Research Site | Rouen | Haute Normandie |
| France | Research Site | Royan | Charente |
| France | Research Site | Sallanches Cedex | Dauphine |
| France | Research Site | Salon de Provence | Provence |
| France | Research Site | Salon de Provence Cedex | Provence |
| France | Research Site | Sarcelles | Vexin |
| France | Research Site | Savigny Sur Orge | Brie |
| France | Research Site | Semur En Auxois | Bourgogne |
| France | Research Site | Sete | Catalogne |
| France | Research Site | St Amand Montrond | Limousin |
| France | Research Site | St Avold | Lorraine |
| France | Research Site | St Chamond | Auvergne Stephanois |
| France | Research Site | St Etienne | Auvergne Stephanois |
| France | Research Site | St Jean de Luz | Aquitaine Sud |
| France | Research Site | St Martin D Aubigny | Basse Normandie |
| France | Research Site | St Raphael | Esterel |
| France | Research Site | St Yrieix La Perche | Limousin |
| France | Research Site | Tarbes | Aquitaine Sud |
| France | Research Site | Tonnerre | Sologne |
| France | Research Site | Toulon | Maures Corse |
| France | Research Site | Toulon Cedex | Maures Corse |
| France | Research Site | Tours | Touraine |
| France | Research Site | Valenciennes Cedex | Picardie |
| France | Research Site | Valognes | Basse Normandie |
| France | Research Site | Vesoul Cedex | Aube Franche Comte |
| France | Research Site | Villefranche de Rouergue | Languedoc |
| France | Research Site | Villiers Sur Orge | Touraine |
| France | Research Site | Wattrelos Cedex | Flandres |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | Takeda |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Profile of patients treated with candesartan for heart failure | At inclusion | No | |
| Secondary | Percentage of patients taking correctly its treatment : indication, contraindication, drug titration, treatment monitoring | 6 and 12 months after | No | |
| Secondary | Percentage of patients stopping its treatment and reasons why | 12 months after | No | |
| Secondary | Percentage of hospitalisations due to heart failure and cardiovascular deaths | 12 months after | No |
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