ClinicalTrials.gov
ClinicalTrials.gov Menu

Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France (SISTOLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00679640
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : December 2, 2010
Sponsor:
Collaborator:
Takeda
Information provided by:
AstraZeneca

Brief Summary:
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

Condition or disease Intervention/treatment
Heart Failure Cohort Study Drug: Candesartan

Study Type : Observational
Actual Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France
Study Start Date : January 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
1
Outpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure
Drug: Candesartan
Oral tablets
Other Name: Atacand




Primary Outcome Measures :
  1. Profile of patients treated with candesartan for heart failure [ Time Frame: At inclusion ]

Secondary Outcome Measures :
  1. Percentage of patients taking correctly its treatment : indication, contraindication, drug titration, treatment monitoring [ Time Frame: 6 and 12 months after ]
  2. Percentage of patients stopping its treatment and reasons why [ Time Frame: 12 months after ]
  3. Percentage of hospitalisations due to heart failure and cardiovascular deaths [ Time Frame: 12 months after ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients seen in outpatient care (private consultation or outpatient hospital consultation) at the baseline visit
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679640


  Hide Study Locations
Locations
France
Research Site
Mulhouse Cedex 1, Alsace, France
Research Site
Bordeaux, Aquitaine Nord, France
Research Site
Dax Cedex, Aquitaine Sud, France
Research Site
St Jean de Luz, Aquitaine Sud, France
Research Site
Tarbes, Aquitaine Sud, France
Research Site
Arras Cedex, Artois, France
Research Site
Bethune, Artois, France
Research Site
Besancon Cedex, Aube Franche Comte, France
Research Site
Langres Cedex, Aube Franche Comte, France
Research Site
Vesoul Cedex, Aube Franche Comte, France
Research Site
Clermont Ferrand, Auvergne Stephanois, France
Research Site
St Chamond, Auvergne Stephanois, France
Research Site
St Etienne, Auvergne Stephanois, France
Research Site
Caen Cedex 1, Basse Normandie, France
Research Site
Caen Cedex 4, Basse Normandie, France
Research Site
Granville Cedex, Basse Normandie, France
Research Site
Mayenne Cedex, Basse Normandie, France
Research Site
St Martin D Aubigny, Basse Normandie, France
Research Site
Valognes, Basse Normandie, France
Research Site
Dijon, Bourgogne, France
Research Site
Dole Cedex, Bourgogne, France
Research Site
Paray Le Monial Cedex, Bourgogne, France
Research Site
Semur En Auxois, Bourgogne, France
Research Site
Lannion Cedex, Bretagne Nord, France
Research Site
Rennes, Bretagne Nord, France
Research Site
Morlaix Cedex, Bretagne Sud, France
Research Site
Bry Sur Marne Cedex, Brie, France
Research Site
Meaux Cedex, Brie, France
Research Site
Meaux, Brie, France
Research Site
Savigny Sur Orge, Brie, France
Research Site
Beziers Cedex, Catalogne, France
Research Site
Beziers, Catalogne, France
Research Site
Perpignan, Catalogne, France
Research Site
Sete, Catalogne, France
Research Site
Epernay, Champagne Ardennes, France
Research Site
Chateau D Olonne, Charente, France
Research Site
Niort, Charente, France
Research Site
Poitiers Cedex, Charente, France
Research Site
Royan, Charente, France
Research Site
Annecy Le Vieux, Dauphine, France
Research Site
Annemasse, Dauphine, France
Research Site
Sallanches Cedex, Dauphine, France
Research Site
Nice, Esterel, France
Research Site
St Raphael, Esterel, France
Research Site
Hazebrouck, Flandres, France
Research Site
Lille Cedex, Flandres, France
Research Site
Wattrelos Cedex, Flandres, France
Research Site
Castelsarrasin, Gascogne, France
Research Site
Montauban, Gascogne, France
Research Site
Perigueux Cedex, Gascogne, France
Research Site
Perigueux, Gascogne, France
Research Site
Rouen, Haute Normandie, France
Research Site
Boulogne Billancourt Cedex, Hauts de Seine, France
Research Site
Arles, Languedoc, France
Research Site
Montpellier, Languedoc, France
Research Site
Nimes, Languedoc, France
Research Site
Rodez, Languedoc, France
Research Site
Villefranche de Rouergue, Languedoc, France
Research Site
Limoges, Limousin, France
Research Site
St Amand Montrond, Limousin, France
Research Site
St Yrieix La Perche, Limousin, France
Research Site
Nancy, Lorraine, France
Research Site
St Avold, Lorraine, France
Research Site
Bourgoin Jallieu, Lyonnais, France
Research Site
Bron Cedex, Lyonnais, France
Research Site
Gleize, Lyonnais, France
Research Site
Lyon Cedex 03, Lyonnais, France
Research Site
Rillieux La Pape Cedex, Lyonnais, France
Research Site
Cogolin, Maures Corse, France
Research Site
Hyeres, Maures Corse, France
Research Site
Toulon Cedex, Maures Corse, France
Research Site
Toulon, Maures Corse, France
Research Site
Castanet Tolosan, Midi Pyrenees, France
Research Site
Muret Cedex, Midi Pyrenees, France
Research Site
Paris Cedex 04, Paris Centre, France
Research Site
Paris Cedex 15, Paris Centre, France
Research Site
Paris, Paris Centre, France
Research Site
Aulnay Sous Bois, Paris Nord Est, France
Research Site
Montfermeil, Paris Nord Est, France
Research Site
Montreuil Cedex, Paris Nord Est, France
Research Site
Montreuil, Paris Nord Est, France
Research Site
Chateaubriant, Pays de Loire, France
Research Site
Nantes, Pays de Loire, France
Research Site
Amiens Cedex 3, Picardie, France
Research Site
Conde Sur L Escaut, Picardie, France
Research Site
Valenciennes Cedex, Picardie, France
Research Site
Allauch Cedex, Provence, France
Research Site
Marseille, Provence, France
Research Site
Rognac, Provence, France
Research Site
Salon de Provence Cedex, Provence, France
Research Site
Salon de Provence, Provence, France
Research Site
La Source, Sologne, France
Research Site
Montargis, Sologne, France
Research Site
Orleans, Sologne, France
Research Site
Tonnerre, Sologne, France
Research Site
Arpajon, Touraine, France
Research Site
Chambray Les Tours Cedex, Touraine, France
Research Site
Tours, Touraine, France
Research Site
Villiers Sur Orge, Touraine, France
Research Site
APT, Vallee Du Rhone, France
Research Site
Chateaurenard, Vallee Du Rhone, France
Research Site
Gap Cedex, Vallee Du Rhone, France
Research Site
Beauchamp, Vexin, France
Research Site
Beauvais Cedex, Vexin, France
Research Site
Cergy, Vexin, France
Research Site
Chelles, Vexin, France
Research Site
Creil Cedex 1, Vexin, France
Research Site
Pontoise, Vexin, France
Research Site
Sarcelles, Vexin, France
Research Site
Evecquemont, Yvelines, France
Research Site
Gennevilliers, Yvelines, France
Research Site
Maisons Laffitte, Yvelines, France
Sponsors and Collaborators
AstraZeneca
Takeda
Investigators
Principal Investigator: Stephane Bouee, MD, MSc CEMKA EVAL - Bourg La Reine - France
Study Chair: Luc Hittinger, MD, Prof Hôpital Henri Mondor - Service de cardiologie - Créteil - France

Responsible Party: Deborah Watts, Astrazeneca
ClinicalTrials.gov Identifier: NCT00679640     History of Changes
Other Study ID Numbers: NIS-CFR-ATA-2007/1
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: December 2, 2010
Last Verified: July 2010

Keywords provided by AstraZeneca:
candesartan
heart failure
cohort study
France

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Candesartan
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action