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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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ISRCTN |
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Last refreshed on:
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26 June 2023 |
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Main ID: |
ISRCTN87465420 |
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Date of registration:
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07/05/2015 |
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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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Quality of adherence to guideline recommendations for life-saving treatment in heart failure: an international survey
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Scientific title:
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QUAlity of adherence to guideline recommendations for LIfe-saving treatment in heart failure: an international surveY: an observational study |
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Date of first enrolment:
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01/09/2013 |
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Target sample size:
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7092 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN87465420 |
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Study type:
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Observational |
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Study design:
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Prospective observational longitudinal survey (Other)
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Phase:
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Not Applicable
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Countries of recruitment
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Armenia
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Australia
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Austria
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Azerbaijan
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Bahrain
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Belarus
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Brunei
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Canada
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China
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Denmark
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Egypt
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Georgia
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Germany
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Greece
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Hungary
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Ireland
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Jordan
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Kazakhstan
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Korea, South
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Kuwait
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Lebanon
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Lithuania
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Malaysia
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Morocco
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Oman
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Poland
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Portugal
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Qatar
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Romania
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Russian Federation
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Slovakia
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Spain
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Thailand
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Turkey
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Ukraine
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United Arab Emirates
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Contacts
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Name:
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Michel
Komajda |
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Address:
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Groupe Hospitalier Pitie - Salpetriere
Département de Cardiologie
47/83 boulevard de l'Hôpital
75013
Paris
France |
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Telephone:
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Email:
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Affiliation:
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Name:
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Address:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Outpatients with chronic heart failure:
1. > 18 years of age
2. Hospitalised for worsening of heart failure within 1–15 months
3. With LVSD as demonstrated by left ventricular ejection fraction = 40% measured using the most recent echocardiogram (= 2 years)
4. Validation of rhythm at inclusion
Exclusion criteria: 1. Patients on waiting list for heart transplantation or planned implantation of left ventricular assist device; planned cardiac resynchronisation therapy and implantable cardioverter defibrillators are permitted
2. Patients with planned revascularisation
3. Patients hospitalised for cardiovascular disease within the past 4 weeks
4. Conditions hampering participation or the 18-month follow-up
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Heart failure
Circulatory System
Heart disease
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Intervention(s)
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Non-interventional survey
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Primary Outcome(s)
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1 To evaluate physician’s adherence to HF guidelines by measuring prescriptions modalities of recommended HF medications
2. To calculate an adherence score
3. To analyze the reasons for non-adherence
4. To assess the impact of adherence level on clinical outcomes
Measured at baseline and at 6, 12 and 18 months.
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Secondary Outcome(s)
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To characterize the clinical characteristics and management of outpatients with HF and left ventricular systolic dysfunction (LVSD).
Measured at baseline and at 6, 12 and 18 months.
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Source(s) of Monetary Support
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Servier (France)
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; Ethics approval obtained in every country in accordance with local regulations. All 557 centres obtained ethics approval before recruitment of the first participant (the first approval was obtained on 10/06/2013 from the Ethics Committee at the National Institute of Cardiovascular Diseases, Slovakia; approval for the last site was on 20/09/2014 from McGill University Health Centre Biomedical D, Canada).
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/09/2018 |
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URL:
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