Overview

Efficacy of ACE Inhibitors, MRAs and ACE Inhibitor/ MRA Combination

Status:
Recruiting
Trial end date:
2020-03-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of our work is to compare the antiproteinuric efficacy of ACEI monotherapy, Selective MRA monotherapy and their combination in mildly hypertensive patients with type 2 diabetes mellitus and microalbuminuria
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beni-Suef University
Treatments:
Angiotensin-Converting Enzyme Inhibitors
Eplerenone
Ramipril
Criteria
Inclusion Criteria:

- Adult male and non-pregnant female patients with established diagnosis of type 2 DM at
least five years ago with glycosylated hemoglobin (HbA1c) ≤ 8.5%

- Age 30-80 Y

- Stage 1 hypertension (systolic BP 140-159 mmHg and/or diastolic BP 90-99 mmHg) and
microalbuminuria diagnosed by measuring Urinary albumin/creatinine ratio (UACR) .
Microalbuminuria was defined at a level between (30-300 mg/g)

- Patients included in our study had never been treated with ACEIs, ARBs or aldosterone
antagonists, serum potassium level ≥ 3.5 and ≤ 5.0 mmol/L before randomization with
estimated glomerular filtration rate (e GFR) ≥50 mL/min/1.73 m2

Exclusion Criteria:

- Patients with type 1 diabetes mellitus

- Patients with BP ≥ 160/100 mmHg

- Patients with secondary hypertension

- Non-diabetic nephropathy including (chronic glomerulonephritis, polycystic kidney
disease and nephrosclerosis),

- Confirmed bilateral renal artery stenosis or stenosis of the renal artery in solitary
functioning kidney

- History of New York Heart Association functional class III and IV heart failure

- Patients with rapid progression of kidney disease and women who were pregnant,
breast-feeding, or planning to become pregnant during the study period