Hypertension Related Damage to the Microcirculation in South Asian: Emergence, Predictive Power and Reversibility

NCT00331370 | Unknown

• 1 other identifier: DHCPP00493
• Study Type: interventional
• Target: 2,880
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Diabetes; Cardiovascular Disease; Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

GP training and Health Education BEHAVIORAL

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects aged 9 years or over residing in randomly selected communities

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead
• Imperial College London: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Cardiovascular Diseases; Retinal Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Eye Diseases

Study Officials

• Tazeen H Jafar, MD, MPH

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Nish Chaturvedi, MD, MFPHM

  Imperial College London

  STUDY CHAIR

• Alun Hughes, MD, Phd

  Imperial College London

  STUDY CHAIR

• Juanita Hatcher, Phd, MSc

  Aga Khan University

  STUDY CHAIR

• Simon Thom, MD, FRCP

  Imperial College London

  STUDY CHAIR

• Khabir Ahmad, MD, MSc

  Aga Khan University

  STUDY CHAIR

• Muhammad Saleem Khan, MSc Epi&Bio

  Aga Khan University

  STUDY CHAIR

Central Study Contacts

Tazeen H Jafar, Md,MPH

CONTACT

0092-4930051; tazeen.jafar@aku.edu

Muhamamd Saleem Khan, MSc Epi&Bio

CONTACT

0092-4930051; muhammad.saleem@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: May 31, 2006
• Study Start: May 1, 2006
• Study Completion: June 1, 2009
• Last Updated: May 31, 2006

Record last verified: 2006-05

Locations

PA (1)