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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:
Information provided by:

May 15, 2008
May 19, 2008
December 2, 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 ]
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 ]
  • Percentage of patients stopping its treatment and reasons why [ Time Frame: 12 months after ]
  • Percentage of hospitalisations due to heart failure and cardiovascular deaths [ Time Frame: 12 months after ]
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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
France
China
 
NCT00679640
NIS-CFR-ATA-2007/1
Yes
Not Provided
Not Provided
Deborah Watts, Astrazeneca
AstraZeneca
Takeda
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