None listed
Conditions
Brief summary
Objective: To evaluate whether the development of albuminuria, hypertension or diabetes can be delayed or postponed in high risk Aboriginal people. Design. Double blind, placebo controlled, randomized trial of a long acting angiotensin converting enzyme inhibitor(ACEi), titrated to full dose where tolerated (active arm) vs placebo. Oversight: A steering committee, an independent audit process and a data analysis group. Eligibility criteria: Consenting Aboriginal adults age 18+ years, with BP = 140/90, urine albumin creatinine ratio < 2.2 gm/mol and without diabetes, who are without contraindications to ACEi. Outcomes: The primary outcome is a composite endpoint for BP>140/90 and/or urine ACR>2.2 gm/mol and or diabetes. Weight, waist, lipids and HbA1c levels will also be followed. Cardiovascular events and natural deaths will be documented. Sample size: A total of 150 candidates is proposed: the Tiwi community. These will represent at least 75 in the active arm and 75 in the placebo arm. The sample size is based on factual incidence data in Tiwi. Duration: Five years of active treatment, with an option to discontinue earlier pending significant results Significance: Delay of onset of features of the vascular/metabolic/renal syndrome in populations where annual incidence rates are as high as 15% per year, and prevalence rates by age 50 years are = 80% could save or prevent much morbidity and mortality from definitive disease. Findings will probably be relevant to other high risk population.
Interventions
Oral once daily dosage of Coversyl (Perindopril), a long acting angiotensin converting enzyme inhibitor(ACEi)
Masked participants will be commenced on 5mg of Coversyl (Perindopril) oral daliy for four weeks, then titrated to the full oral daily dose of 10mg Coversyl (Perindopril) where tolerated. Participants are requested to participate in the study for up to 5 years from there date of enrollment.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Consenting Tiwi Aboriginal adults age 18+ years BP less then or equal to 140/90 Urine albumin creatinine ratio less then 3.4 gm/mol Without diabetes Who are without contraindications to ACEi.
Exclusion criteria
Contraindications to or history of intolerance to ACEi. Other diseases which might interfere with, or contraindicate treatment. Emotional or intellectual issues that might invalidate participants consent and/or limit the ability of the participant to comply with protocol requirements. Women of childbearing potential who are not on long-term contraception.
Outcome results
None listed