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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.
Register: ISRCTN
Last refreshed on: 13 January 2015
Main ID:  ISRCTN48141450
Date of registration: 07/06/2005
Prospective Registration: No
Primary sponsor: The Department of Cardiovascular Diseases (CVD)/World Health Organization (WHO) (Switzerland)
Public title: Evaluation of World Health Organisation (WHO) cardiovascular disease (CVD)-risk management package - scenario one (Sri Lanka)
Scientific title:
Date of first enrolment: 07/05/2004
Target sample size: 0
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN48141450
Study type:  Interventional
Study design:  Randomised controlled trial (Treatment)  
Phase: 
Countries of recruitment
Sri Lanka
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: S    Mendis
Address:  20, Avenue Appia CH 1211 Geneva-27 Switzerland
Telephone:
Email: mendiss@who.int
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Age 30 - 70 years
2. Currently not under treatment for hypertension
3. Systolic blood pressure between 140 and 179 mmHg measured twice with a 5 to 10 minute interval
4. Informed consent given

Exclusion criteria: 1. Pregnancy
2. Trauma (injury) as presenting complaint
3. Renal diseases: nephropathy, renal artery stenosis
4. Endocrinological (hormonal) disorders: phaechromocytoma, Cushing syndrome, Conn syndrome, acromegaly
5. Coarctation of the aorta
6. Use of steroids and/or non-steroidal anti-inflammatories (NSAIs)
7. All acute conditions presenting with bleeding, pain, diarrhoea, vomiting, breathing disorders and circulatory disorders
8. Inability to comply with the follow-up requirements
9. Inability to provide informed consent


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Hypertension
Circulatory System
Hypertension
Intervention(s)
20 primary health care facilities.
10 facilities to apply the study protocol based on Scenario One of the WHO CVD-Risk Management Package (intervention sites).
Other 10 to continue with conventional treatment or usual care (control sites).
Primary Outcome(s)
Not provided at time of registration
Secondary Outcome(s)
Not provided at time of registration
Secondary ID(s)
RPC050
Source(s) of Monetary Support
The Department of Cardiovascular Diseases (CVD)/World Health Organization (WHO) (Switzerland)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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