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

NCT04143412 | Unknown Phase 2

• 1 other identifier: RAAS blockers in albuminuria
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetic Nephropathy Type 2; Microalbuminuria Due to Type 2 Diabetes Mellitus

Keywords

microalbuminuria; Diabetic nephropathy; Hperkalemia; Eplerenone; Ramipril

Outcome Measures

Primary Outcomes (1)

• Urinary albumin/creatinin ratio (UACR)

  Percentage change in albumin/creatinin ratio compared with the baseline value

  24 weeks

Secondary Outcomes (3)

• Blood pressure

  24 weeks

• estimated Glomerular Filtration Rate (e GFR)

  24 weeks

• Serum K

  24 weeks

Study Arms (3)

Tritace (Ramipril)

ACTIVE COMPARATOR

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

Drug: Tritace (Ramipril 10 mg)

Eraloner (Eplerenone)

ACTIVE COMPARATOR

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

Drug: Tritace (Ramipril 10 mg)

Tritace/Eraloner (Ramipril/Eplerenone)combination therapy

ACTIVE COMPARATOR

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

Drug: Tritace (Ramipril 10 mg)

Interventions

Tritace (Ramipril 10 mg) DRUG

Stratified randomized clinical trial

Also known as: Eraloner (Eplerenone 50 mg), Tritace/ Eraloner (Ramipril 10 mg/ Eplerenone 50 mg)

Eraloner (Eplerenone); Tritace (Ramipril); Tritace/Eraloner (Ramipril/Eplerenone)combination therapy

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Faculty of Medicine,Beni-Suef University

Banī Suwayf, 62511, Egypt

RECRUITING

Related Publications (8)

• 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.

  PMID: 26239461 BACKGROUND

• 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.

  PMID: 19825147 BACKGROUND

• 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.

  PMID: 24843491 BACKGROUND

• 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.

  PMID: 27536666 BACKGROUND

• 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.

  PMID: 20535265 BACKGROUND

• 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.

  PMID: 18580865 BACKGROUND

• 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.

  PMID: 20730071 BACKGROUND

• 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.

  PMID: 29275368 BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Ramipril; Eplerenone

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mostafa O El Mokadem, M.D.

  Cardiology department,Faculty of Medicine, Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa O El Mokadem, M.D.

CONTACT

+201009414408; mostafa.elmokadem9@med.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three parallel groups of therapy; Ramipril 10 mg monotherapy (25 patients) ,Eplerenone 50 mg monotherapy (25 patients) and combination therapy of Eplernone/Ramipril 50/10 mg (25 patients)

Study Record Dates

• First Submitted: October 26, 2019
• First Posted: October 29, 2019
• Study Start: February 4, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)