Hypertension Clinical Trial
Official title:
Hypertension Related Damage to the Microcirculation in South Asian: Emergence,Predictive Power and Reversibility
Damage to very small blood vessels is a consequence, but can also precede high blood pressure. Such damage, measured by disturbances in the vessels in the retina (back of the eye) is a strong predictor of heart disease and stroke. South Asian people have one of the highest rates of hypertension in the world (30% in adults). In Pakistan, this is usually severe, undetected and untreated. The Wellcome Trust has already funded a study of blood pressure control in adults and children in this population. We propose a substudy, taking photographs of the retina and making measurements of the vessels, to determine whether such blood pressure related changes occur at an early age in young children with a family history of high blood pressure compared to those without, whether such changes predict an increase in blood pressure over time, and whether, in adults, such changes can be reversed by blood pressure treatment. The hypothesis of our study is: young offspring of South Asian people with hypertension have a disturbed microcirculation, as assessed by abnormalities of retinal vessels, compared to offspring of normotensive parents. Our 2nd hypothesis is: Abnormal retinal vascular geometry will improve proportionately to achieved reductions in BP.
Status | Not yet recruiting |
Enrollment | 2880 |
Est. completion date | June 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 9 Years and older |
Eligibility |
Inclusion Criteria: All subjects aged 9 years or over residing in randomly selected communities Exclusion Criteria: Pregnancy Those who have severe co-morbid conditions Patients with known history of glaucoma will be excluded from our study because instillation of mydriatic drops was thought to be hazardous for them. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Pakistan | Aga Khan University | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Aga Khan University | Imperial College London |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary outcome would be abnormal retinal geometry defined as the composite outcome of a) abnormal arteriolar length: diameter, b) narrowed branching angles, or c) disturbed junction exponents. |
Status | Clinical Trial | Phase | |
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