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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00679640
First Posted: May 19, 2008
Last Update Posted: December 2, 2010
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.
Collaborator:
Takeda
Information provided by:
AstraZeneca
  Purpose
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 Intervention
Heart Failure Cohort Study Drug: Candesartan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 450
Study Start Date: January 2008
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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


  Show 112 Study Locations
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
  More Information

Responsible Party: Deborah Watts, Astrazeneca
ClinicalTrials.gov Identifier: NCT00679640     History of Changes
Other Study ID Numbers: NIS-CFR-ATA-2007/1
First Submitted: May 15, 2008
First Posted: May 19, 2008
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