Efficacy of ACE Inhibitors, MRAs and ACE Inhibitor/ MRA Combination
NCT ID: NCT04143412
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
75 participants
INTERVENTIONAL
2019-02-04
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tritace (Ramipril)
25 patients with type 2 diabetes mellitus and mild hypertension will be randomized to Tritace (Ramipril) 10 mg/ day. Full doses will be reached by forced titration after 4 weeks
Tritace (Ramipril 10 mg)
Stratified randomized clinical trial
Eraloner (Eplerenone)
25 patients with type 2 diabetes mellitus and mild hypertension will be randomized to Eraloner (Eplerenone) 50 mg/ day. Full doses will be reached by forced titration after 4 weeks
Tritace (Ramipril 10 mg)
Stratified randomized clinical trial
Tritace/Eraloner (Ramipril/Eplerenone)combination therapy
25 patients with type 2 diabetes mellitus and mild hypertension will be randomized to Tritace/Eraloner (Ramipril 10 mg / Eplerenone 50 mg ) / day. Full doses will be reached by forced titration after 4 weeks
Tritace (Ramipril 10 mg)
Stratified randomized clinical trial
Interventions
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Tritace (Ramipril 10 mg)
Stratified randomized clinical trial
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
30 Years
80 Years
ALL
No
Sponsors
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Beni-Suef University
OTHER
Responsible Party
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Mostafa El Mokadem
Principal Investigator
Principal Investigators
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Mostafa O El Mokadem, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cardiology department,Faculty of Medicine, Beni-Suef University
Locations
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Faculty of Medicine,Beni-Suef University
Banī Suwayf, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Espinel E, Agraz I, Ibernon M, Ramos N, Fort J, Seron D. Renal Biopsy in Type 2 Diabetic Patients. J Clin Med. 2015 May 18;4(5):998-1009. doi: 10.3390/jcm4050998.
Zelmanovitz T, Gerchman F, Balthazar AP, Thomazelli FC, Matos JD, Canani LH. Diabetic nephropathy. Diabetol Metab Syndr. 2009 Sep 21;1(1):10. doi: 10.1186/1758-5996-1-10.
Cao Z, Cooper ME. Pathogenesis of diabetic nephropathy. J Diabetes Investig. 2011 Aug 2;2(4):243-7. doi: 10.1111/j.2040-1124.2011.00131.x.
Satirapoj B, Adler SG. Prevalence and Management of Diabetic Nephropathy in Western Countries. Kidney Dis (Basel). 2015 May;1(1):61-70. doi: 10.1159/000382028. Epub 2015 May 1.
Jalal S, Sofi FA, Abass SM, Alai MS, Bhat MA, Rather HA, Lone NA, Siddiqi MA. Effect of amlodipine and lisinopril on microalbuminuria in patients with essential hypertension: A prospective study. Indian J Nephrol. 2010 Jan;20(1):15-20. doi: 10.4103/0971-4065.62090.
Galle J. Reduction of proteinuria with angiotensin receptor blockers. Nat Clin Pract Cardiovasc Med. 2008 Jul;5 Suppl 1:S36-43. doi: 10.1038/ncpcardio0806.
Cagnoni F, Njwe CA, Zaninelli A, Ricci AR, Daffra D, D'Ospina A, Preti P, Destro M. Blocking the RAAS at different levels: an update on the use of the direct renin inhibitors alone and in combination. Vasc Health Risk Manag. 2010 Aug 9;6:549-59. doi: 10.2147/vhrm.s11816.
Cooper LB, Lippmann SJ, Greiner MA, Sharma A, Kelly JP, Fonarow GC, Yancy CW, Heidenreich PA, Hernandez AF. Use of Mineralocorticoid Receptor Antagonists in Patients With Heart Failure and Comorbid Diabetes Mellitus or Chronic Kidney Disease. J Am Heart Assoc. 2017 Dec 23;6(12):e006540. doi: 10.1161/JAHA.117.006540.
Other Identifiers
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RAAS blockers in albuminuria
Identifier Type: -
Identifier Source: org_study_id
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