Effect of Renin-angiotensin System Blockers on Glomerular Filtration Rate in Patients With Hypertension, Type 2 Diabetes With Normoalbuminuria

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

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 often used as an early predictor of diabetic nephropathy. Many studies already demonstrated the renoprotective effect of Renin-angiotensin-system (RAS) blockers in patients with varying degree of albuminuria, few studies focus on studying the decline in glomerular filtration rate (GFR) among patients with normoalbuminuria. However a substantial number of diabetic patients exist with sub-normal GFR without microalbumin excretion. From literature, diabetes mellitus will have faster decline in GFR but the investigators do not know whether such decline can be slowed down by the use of RAS blockers as compared with other anti-hypertensive drugs. This Study investigate the effect of early treatment with RAS blockers on the decline rate of GFR in diabetic patients with normoalbuminuria.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Authority, Hong Kong
• Treatments: Amlodipine; Irbesartan; Methyldopa; Ramipril

Criteria

Inclusion criteria:

1. Age >=35 - 80 years old who is capable to give consent

2. Chinese

3. 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)

4. 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.

5. 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:

1. Patients currently on ACEI or ARB as their anti-hypertensive medication

2. Pregnancy

3. Type 1 diabetes

4. Non-diabetic renal disease including renal artery stenosis

5. Secondary hypertension

6. History of symptomatic heart failure

7. History of myocardial infarction within 6 months

8. Specific indication for or contraindication to use ACEI or ARB

9. History of allergy to ACEI or ARB