Efficacy of ACE Inhibitors, MRAs and ACE Inhibitor/ MRA Combination (NCT04143412) | Clinical Trial Compass
UnknownPhase 2
Efficacy of ACE Inhibitors, MRAs and ACE Inhibitor/ MRA Combination
Egypt75 participantsStarted 2019-02-04
Plain-language 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
Who can participate
Age range30 Years – 80 Years
SexALL
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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