Status:
UNKNOWN
Effect of Renin-angiotensin System Blockers on Glomerular Filtration Rate in Patients With Hypertension, Type 2 Diabetes With Normoalbuminuria
Lead Sponsor:
Hospital Authority, Hong Kong
Conditions:
Diabetes
Hypertensive Disease
Eligibility:
All Genders
35-80 years
Phase:
PHASE4
Brief Summary
Diabetes is the leading cause of chronic kidney disease in developed countries. About 30-40% of patients with type 1 and type 2 diabetes mellitus will develop diabetic nephropathy. Microalbuminuria is...
Detailed Description
Renal excretory function, represented by GFR, deteriorates with age. After age 20-30 years, GFR declines by 1ml/min per year. This age related loss of renal function is proportional to blood pressure ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age \>=35 - 80 years old who is capable to give consent
- Chinese
- Either (i) Type 2 diabetes mellitus (DM) diagnosed according to ADA guideline or (ii) Hypertension defined as systolic blood pressure \>140 or diastolic \>90 mmHg or taking anti-hypertensive medication to attain blood pressure under these level or having (i) and (ii)
- Estimated GFR (eGFR) (based on blood test taken 3 months prior to the date of consent) 60 - 89 ml/min/1.73m2 calculated by the abbreviated 4 variable Modification of Diet in Renal Disease (MDRD) study equation and no other identified causes of renal insufficiency.
- Normoalbuminuria determined by urine albumin to creatinine ratio (based on urine test taken 3 months prior to the date of consent) \<2.5 mg/mmol for men or \<3.5 mg/mmol for women in first morning void urine sample.
- Exclusion criteria:
- Patients currently on ACEI or ARB as their anti-hypertensive medication
- Pregnancy
- Type 1 diabetes
- Non-diabetic renal disease including renal artery stenosis
- Secondary hypertension
- History of symptomatic heart failure
- History of myocardial infarction within 6 months
- Specific indication for or contraindication to use ACEI or ARB
- History of allergy to ACEI or ARB
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT01500590
Start Date
November 1 2011
End Date
August 1 2019
Last Update
September 5 2016
Active Locations (1)
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1
Hospital Authority, HKEC, FM&PHC
Hong Kong, China