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

This study has been completed.
Sponsor:
Collaborator:
Takeda Global Research & Development Center, Inc.
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00679640
First received: May 15, 2008
Last updated: December 1, 2010
Last verified: July 2010
History of Changes

May 15, 2008
December 1, 2010
January 2008
June 2010   (final data collection date for primary outcome measure)
Profile of patients treated with candesartan for heart failure [ Time Frame: At inclusion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00679640 on ClinicalTrials.gov Archive Site
  • Percentage of patients taking correctly its treatment : indication, contraindication, drug titration, treatment monitoring [ Time Frame: 6 and 12 months after ] [ Designated as safety issue: No ]
  • Percentage of patients stopping its treatment and reasons why [ Time Frame: 12 months after ] [ Designated as safety issue: No ]
  • Percentage of hospitalisations due to heart failure and cardiovascular deaths [ Time Frame: 12 months after ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France
Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France

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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients seen in outpatient care (private consultation or outpatient hospital consultation) at the baseline visit
  • Heart Failure
  • Cohort Study
Drug: Candesartan
Oral tablets
Other Name: Atacand
1
Outpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure
Intervention: Drug: Candesartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
July 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00679640
NIS-CFR-ATA-2007/1
Yes
Deborah Watts, Astrazeneca
AstraZeneca
Takeda Global Research & Development Center, Inc.
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
AstraZeneca
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP