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

December 1, 2010 updated by: AstraZeneca
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alsace
      • Mulhouse Cedex 1, Alsace, France
        • Research Site
    • Aquitaine Nord
      • Bordeaux, Aquitaine Nord, France
        • Research Site
    • Aquitaine Sud
      • Dax Cedex, Aquitaine Sud, France
        • Research Site
      • St Jean de Luz, Aquitaine Sud, France
        • Research Site
      • Tarbes, Aquitaine Sud, France
        • Research Site
    • Artois
      • Arras Cedex, Artois, France
        • Research Site
      • Bethune, Artois, France
        • Research Site
    • Aube Franche Comte
      • Besancon Cedex, Aube Franche Comte, France
        • Research Site
      • Langres Cedex, Aube Franche Comte, France
        • Research Site
      • Vesoul Cedex, Aube Franche Comte, France
        • Research Site
    • Auvergne Stephanois
      • Clermont Ferrand, Auvergne Stephanois, France
        • Research Site
      • St Chamond, Auvergne Stephanois, France
        • Research Site
      • St Etienne, Auvergne Stephanois, France
        • Research Site
    • Basse Normandie
      • 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
    • Bourgogne
      • 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
    • Bretagne Nord
      • Lannion Cedex, Bretagne Nord, France
        • Research Site
      • Rennes, Bretagne Nord, France
        • Research Site
    • Bretagne Sud
      • Morlaix Cedex, Bretagne Sud, France
        • Research Site
    • Brie
      • Bry Sur Marne Cedex, Brie, France
        • Research Site
      • Meaux, Brie, France
        • Research Site
      • Meaux Cedex, Brie, France
        • Research Site
      • Savigny Sur Orge, Brie, France
        • Research Site
    • Catalogne
      • Beziers, Catalogne, France
        • Research Site
      • Beziers Cedex, Catalogne, France
        • Research Site
      • Perpignan, Catalogne, France
        • Research Site
      • Sete, Catalogne, France
        • Research Site
    • Champagne Ardennes
      • Epernay, Champagne Ardennes, France
        • Research Site
    • Charente
      • Chateau D Olonne, Charente, France
        • Research Site
      • Niort, Charente, France
        • Research Site
      • Poitiers Cedex, Charente, France
        • Research Site
      • Royan, Charente, France
        • Research Site
    • Dauphine
      • Annecy Le Vieux, Dauphine, France
        • Research Site
      • Annemasse, Dauphine, France
        • Research Site
      • Sallanches Cedex, Dauphine, France
        • Research Site
    • Esterel
      • Nice, Esterel, France
        • Research Site
      • St Raphael, Esterel, France
        • Research Site
    • Flandres
      • Hazebrouck, Flandres, France
        • Research Site
      • Lille Cedex, Flandres, France
        • Research Site
      • Wattrelos Cedex, Flandres, France
        • Research Site
    • Gascogne
      • Castelsarrasin, Gascogne, France
        • Research Site
      • Montauban, Gascogne, France
        • Research Site
      • Perigueux, Gascogne, France
        • Research Site
      • Perigueux Cedex, Gascogne, France
        • Research Site
    • Haute Normandie
      • Rouen, Haute Normandie, France
        • Research Site
    • Hauts de Seine
      • Boulogne Billancourt Cedex, Hauts de Seine, France
        • Research Site
    • Languedoc
      • 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
    • Limousin
      • Limoges, Limousin, France
        • Research Site
      • St Amand Montrond, Limousin, France
        • Research Site
      • St Yrieix La Perche, Limousin, France
        • Research Site
    • Lorraine
      • Nancy, Lorraine, France
        • Research Site
      • St Avold, Lorraine, France
        • Research Site
    • Lyonnais
      • 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
    • Maures Corse
      • Cogolin, Maures Corse, France
        • Research Site
      • Hyeres, Maures Corse, France
        • Research Site
      • Toulon, Maures Corse, France
        • Research Site
      • Toulon Cedex, Maures Corse, France
        • Research Site
    • Midi Pyrenees
      • Castanet Tolosan, Midi Pyrenees, France
        • Research Site
      • Muret Cedex, Midi Pyrenees, France
        • Research Site
    • Paris Centre
      • Paris, Paris Centre, France
        • Research Site
      • Paris Cedex 04, Paris Centre, France
        • Research Site
      • Paris Cedex 15, Paris Centre, France
        • Research Site
    • Paris Nord Est
      • Aulnay Sous Bois, Paris Nord Est, France
        • Research Site
      • Montfermeil, Paris Nord Est, France
        • Research Site
      • Montreuil, Paris Nord Est, France
        • Research Site
      • Montreuil Cedex, Paris Nord Est, France
        • Research Site
    • Pays de Loire
      • Chateaubriant, Pays de Loire, France
        • Research Site
      • Nantes, Pays de Loire, France
        • Research Site
    • Picardie
      • Amiens Cedex 3, Picardie, France
        • Research Site
      • Conde Sur L Escaut, Picardie, France
        • Research Site
      • Valenciennes Cedex, Picardie, France
        • Research Site
    • Provence
      • Allauch Cedex, Provence, France
        • Research Site
      • Marseille, Provence, France
        • Research Site
      • Rognac, Provence, France
        • Research Site
      • Salon de Provence, Provence, France
        • Research Site
      • Salon de Provence Cedex, Provence, France
        • Research Site
    • Sologne
      • La Source, Sologne, France
        • Research Site
      • Montargis, Sologne, France
        • Research Site
      • Orleans, Sologne, France
        • Research Site
      • Tonnerre, Sologne, France
        • Research Site
    • Touraine
      • 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
    • Vallee Du Rhone
      • APT, Vallee Du Rhone, France
        • Research Site
      • Chateaurenard, Vallee Du Rhone, France
        • Research Site
      • Gap Cedex, Vallee Du Rhone, France
        • Research Site
    • Vexin
      • 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
    • Yvelines
      • Evecquemont, Yvelines, France
        • Research Site
      • Gennevilliers, Yvelines, France
        • Research Site
      • Maisons Laffitte, Yvelines, France
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients seen in outpatient care (private consultation or outpatient hospital consultation) at the baseline visit

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Atacand

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Profile of patients treated with candesartan for heart failure
Time Frame: At inclusion
At inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients taking correctly its treatment : indication, contraindication, drug titration, treatment monitoring
Time Frame: 6 and 12 months after
6 and 12 months after
Percentage of patients stopping its treatment and reasons why
Time Frame: 12 months after
12 months after
Percentage of hospitalisations due to heart failure and cardiovascular deaths
Time Frame: 12 months after
12 months after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria

May 15, 2008

First Posted (ESTIMATE)

May 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2010

Last Update Submitted That Met QC Criteria

December 1, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CFR-ATA-2007/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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