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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00679640 |
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Date of registration:
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15/05/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France
SISTOLA |
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Scientific title:
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Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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450 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00679640 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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China
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France
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Contacts
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Name:
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Luc Hittinger, MD, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital Henri Mondor - Service de cardiologie - Créteil - France |
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Name:
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Stephane Bouee, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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CEMKA EVAL - Bourg La Reine - France |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cohort Study
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Heart Failure
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Intervention(s)
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Drug: Candesartan
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Primary Outcome(s)
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Profile of patients treated with candesartan for heart failure
[Time Frame: At inclusion]
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Secondary Outcome(s)
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Percentage of patients taking correctly its treatment : indication, contraindication, drug titration, treatment monitoring
[Time Frame: 6 and 12 months after]
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Percentage of hospitalisations due to heart failure and cardiovascular deaths
[Time Frame: 12 months after]
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Percentage of patients stopping its treatment and reasons why
[Time Frame: 12 months after]
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Secondary ID(s)
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NIS-CFR-ATA-2007/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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