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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
  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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Profile of patients treated with candesartan for heart failure [ Time Frame: At inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679640

  Show 112 Study Locations
Sponsors and Collaborators
AstraZeneca
Takeda Global Research & Development Center, Inc.
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

No publications provided

Responsible Party: Deborah Watts, Astrazeneca
ClinicalTrials.gov Identifier: NCT00679640     History of Changes
Other Study ID Numbers: NIS-CFR-ATA-2007/1
Study First Received: May 15, 2008
Last Updated: December 1, 2010
Health Authority: France: Haute Autorité de Santé Transparency Commission

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
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013