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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00416611
Other study ID # HAS-02-231206
Secondary ID
Status Completed
Phase Phase 4
First received December 23, 2006
Last updated January 28, 2009
Start date November 2006
Est. completion date November 2007

Study information

Verified date January 2009
Source Hellenic Atherosclerosis Society
Contact n/a
Is FDA regulated No
Health authority Greece: Ministry of Health and Welfare
Study type Observational

Clinical Trial Summary

The objective of this protocol is to improve awareness, treatment, and control of arterial hypertension, within primary prevention of target organ damage, by implementing guidelines, after training of the participating physicians.


Description:

Physicians from 20 hospitals and 40 health centres (primary health care settings) were trained to implement guidelines in treating arterial hypertension.

There will be a baseline recording of patients with arterial hypertension and then physicians will have to complete a one page form (by ticking pre-specified boxes) about the baseline status of the patients and will have to report the measures they took to improve awareness, treatment, and effective control of arterial hypertension. After a six month effort, physicians will have to complete the same form at study completion. Previous training of physicians and the fact that they will have to report their success in treating hypertension will hopefully contribute to an increase in number of hypertensive patients at blood pressure target, and will minimise the target organ damage. The estimated reduction in coronary heart disease risk will be evaluated by a comparison of this risk (as evaluated by a risk engine, i.e. PROCAM) at study completion with that of baseline.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Arterial hypertension as defined by the JNC 7 report

Exclusion Criteria:

- Pregnancy

- Lactation

- Malignancies with small life expectancy

- Unwillingness to participate

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Implementation of guidelines


Locations

Country Name City State
Greece Hellenic Atherosclerosis Society Thessaloniki

Sponsors (1)

Lead Sponsor Collaborator
Hellenic Atherosclerosis Society

Country where clinical trial is conducted

Greece, 

References & Publications (1)

Karagiannis A, Athyros VG, Papageorgiou A, Tziomalos K, Elisaf M. Should atenolol still be recommended as first-line therapy for primary hypertension? Hellenic J Cardiol. 2006 Sep-Oct;47(5):298-307. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy in arterial hypertension control 6 months No
Primary Efficacy in reducing estimated risk of coronary heart disease 6 months No
Secondary Cost effectiveness of arterial hypertension control 6 months No
Secondary Differences between primary and secondary health care settings as well as teaching hospitals 6 months No
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