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

January 14, 2020 updated by: Mostafa El Mokadem, Beni-Suef University

Antiproteinuric Efficacy of ACE Inhibitors, Selective MRAs and ACE Inhibitor/Selective MRA Combination Therapy in Diabetic Hypertensives With Microalbuminuria

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Diabetic nephropathy (DN) is the most common cause renal failure in Western countries, responsible for 45% of patients on renal replacement therapy.Diabetic nephropathy was characterized in the early stage by increased albumin excretion in urine, known as microalbuminuria. (DN) results from interactions between different pathological factors that include hyperglycemia, increased activity of the renin-angiotensin-aldosterone-system (RAAS), uncontrolled high systemic and glomerular pressure . (DN) optimal therapy continues to evolve. The main lines of treatment include strict glycemic and blood pressure (BP) control. The angiotensin converting enzyme (ACE) inhibitors have been known to reduce proteinuria both in normotensive and hypertensive patients with diabetic nephropathy and in hypertensive individuals with end stage renal failure . The mechanism by which ACE inhibitors exert their effect on proteinuria reduction is still unknown. The control of high systemic arterial pressure can be beneficial by reducing the filtration pressure. However, no association has been found between antihypertensive effect and proteinuria reduction in several studies. Microalbuminuria which is an early sign of nephropathy can be decreased also by use of Angiotensin receptor blockers (ARBs) in patients with type 2 diabetes mellitus . Insufficient blockade of aldosterone may lead to inadequate anti-albuminuric effects. Studies show that renin-angiotensin-aldosterone system inhibition with ACEI/ARB alone sometimes does not achieve optimal renoprotective effects and does not reduce progression of renal disease, despite therapy. Addition of mineralocorticoid receptor antagonists (MRAs) to angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker therapy was found to reduce proteinuria in patients diabetic nephropathy and can delay progression of renal dysfunction.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Banī Suwayf, Egypt, 62511
        • Recruiting
        • Faculty of Medicine,Beni-Suef University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yasser A Abd el hady, M.D.
        • Principal Investigator:
          • Ashref A Wasfy, MBBch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Tritace (Ramipril 10 mg)
Stratified randomized clinical trial
Other Names:
  • Eraloner (Eplerenone 50 mg)
  • Tritace/ Eraloner (Ramipril 10 mg/ Eplerenone 50 mg)
Active Comparator: 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
Drug: Tritace (Ramipril 10 mg)
Stratified randomized clinical trial
Other Names:
  • Eraloner (Eplerenone 50 mg)
  • Tritace/ Eraloner (Ramipril 10 mg/ Eplerenone 50 mg)
Active Comparator: 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
Drug: Tritace (Ramipril 10 mg)
Stratified randomized clinical trial
Other Names:
  • Eraloner (Eplerenone 50 mg)
  • Tritace/ Eraloner (Ramipril 10 mg/ Eplerenone 50 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary albumin/creatinin ratio (UACR)
Time Frame: 24 weeks
Percentage change in albumin/creatinin ratio compared with the baseline value
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 24 weeks
change in blood pressure level
24 weeks
estimated Glomerular Filtration Rate (e GFR)
Time Frame: 24 weeks
change in estimated Glomerular Filtration Rate (e GFR)
24 weeks
Serum K
Time Frame: 24 weeks
change in serum K level
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Mostafa O El Mokadem, M.D., Cardiology department,Faculty of Medicine, Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2019

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

October 26, 2019

First Submitted That Met QC Criteria

October 26, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAAS blockers in albuminuria

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

To respect privacy and confidentiality of our patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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