NCT00679640

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

103 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

December 2, 2010

Status Verified

July 1, 2010

Enrollment Period

2.4 years

First QC Date

May 15, 2008

Last Update Submit

December 1, 2010

Conditions

Keywords

candesartanheart failurecohort studyFrance

Outcome Measures

Primary Outcomes (1)

  • Profile of patients treated with candesartan for heart failure

    At inclusion

Secondary Outcomes (3)

  • Percentage of patients taking correctly its treatment : indication, contraindication, drug titration, treatment monitoring

    6 and 12 months after

  • Percentage of patients stopping its treatment and reasons why

    12 months after

  • Percentage of hospitalisations due to heart failure and cardiovascular deaths

    12 months after

Study Arms (1)

1

Outpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure

Drug: Candesartan

Interventions

Oral tablets

Also known as: Atacand
1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • outpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (103)

Research Site

Mulhouse, Alsace, France

Location

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Bordeaux, Aquitaine Nord, France

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Dax, Aquitaine Sud, France

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Saint-Jean-de-Luz, Aquitaine Sud, France

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Tarbes, Aquitaine Sud, France

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Arras, Artois, France

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Béthune, Artois, France

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Besançon, Aube Franche Comte, France

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Langres, Aube Franche Comte, France

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Vesoul, Aube Franche Comte, France

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Clermont-Ferrand, Auvergne Stephanois, France

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Saint-Chamond, Auvergne Stephanois, France

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Saint-Etienne, Auvergne Stephanois, France

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Caen, Basse Normandie, France

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Granville, Basse Normandie, France

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Mayenne, Basse Normandie, France

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Saint-Martin-d'Aubigny, Basse Normandie, France

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Valognes, Basse Normandie, France

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Dijon, Bourgogne-Franche-Comté, France

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Dole, Bourgogne-Franche-Comté, France

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Paray-le-Monial, Bourgogne-Franche-Comté, France

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Semur-en-Auxois, Bourgogne-Franche-Comté, France

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Lannion, Bretagne Nord, France

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Rennes, Bretagne Nord, France

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Morlaix, Bretagne Sud, France

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Bry-sur-Marne, Brie, France

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Meaux, Brie, France

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Savigny-sur-Orge, Brie, France

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Béziers, Catalogne, France

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Perpignan, Catalogne, France

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Sète, Catalogne, France

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Épernay, Champagne Ardennes, France

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Château-d'Olonne, Charente, France

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Niort, Charente, France

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Poitiers, Charente, France

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Royan, Charente, France

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Annecy-le-Vieux, Dauphine, France

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Annemasse, Dauphine, France

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Sallanches, Dauphine, France

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Nice, Esterel, France

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Saint-Raphaël, Esterel, France

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Hazebrouck, Flandres, France

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Lille, Flandres, France

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Wattrelos, Flandres, France

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Castelsarrasin, Gascogne, France

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Montauban, Gascogne, France

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Périgueux, Gascogne, France

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Rouen, Haute Normandie, France

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Boulogne-Billancourt, Hauts de Seine, France

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Arles, Languedoc, France

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Montpellier, Languedoc, France

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Nîmes, Languedoc, France

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Rodez, Languedoc, France

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Villefranche-de-Rouergue, Languedoc, France

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Limoges, Limousin, France

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Saint-Amand-Montrond, Limousin, France

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Saint-Yrieix-la-Perche, Limousin, France

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Nancy, Lorraine, France

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Saint-Avold, Lorraine, France

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Bourgoin, Lyonnais, France

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Bron, Lyonnais, France

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Gleizé, Lyonnais, France

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Lyon, Lyonnais, France

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Rillieux-la-Pape, Lyonnais, France

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Cogolin, Maures Corse, France

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Hyères, Maures Corse, France

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Toulon, Maures Corse, France

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Castanet-Tolosan, Midi Pyrenees, France

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Muret, Midi Pyrenees, France

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Paris, Paris Centre, France

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Aulnay-sous-Bois, Paris Nord Est, France

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Montfermeil, Paris Nord Est, France

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Montreuil, Paris Nord Est, France

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Châteaubriant, Pays de Loire, France

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Nantes, Pays de Loire, France

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Amiens, Picardie, France

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Condé-sur-l'Escaut, Picardie, France

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Valenciennes, Picardie, France

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Allauch, Provence-Alpes-Côte d'Azur Region, France

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Marseille, Provence-Alpes-Côte d'Azur Region, France

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Rognac, Provence-Alpes-Côte d'Azur Region, France

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Salon-de-Provence, Provence-Alpes-Côte d'Azur Region, France

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La Source, Sologne, France

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Montargis, Sologne, France

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Orléans, Sologne, France

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Tonnerre, Sologne, France

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Arpajon, Touraine, France

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Chambray-lès-Tours, Touraine, France

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Tours, Touraine, France

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Villiers-sur-Orge, Touraine, France

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Apt, Vallee Du Rhone, France

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Châteaurenard, Vallee Du Rhone, France

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Gap, Vallee Du Rhone, France

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Beauchamp, Vexin, France

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Beauvais, Vexin, France

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Cergy, Vexin, France

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Chelles, Vexin, France

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Creil, Vexin, France

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Pontoise, Vexin, France

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Sarcelles, Vexin, France

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Évecquemont, Yvelines, France

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Gennevilliers, Yvelines, France

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Maisons-Laffitte, Yvelines, France

Location

MeSH Terms

Conditions

Heart Failure

Interventions

candesartancandesartan cilexetil

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Stephane Bouee, MD, MSc

    CEMKA EVAL - Bourg La Reine - France

    PRINCIPAL INVESTIGATOR
  • Luc Hittinger, MD, Prof

    Hôpital Henri Mondor - Service de cardiologie - Créteil - France

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 19, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

December 2, 2010

Record last verified: 2010-07

Locations