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Comparison Between Losartan and Benazepril in Diabetic Hypertensive Patients Not Controlled by Amlodipine (CONTROL)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ronaldo Altenburg Odebrecht Curi Gismondi, Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier:
NCT01603940
First received: May 20, 2012
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to compare losartan and benazepril in diabetic patients whose high blood pressure is not controlled by amlodipine.


Condition Intervention Phase
Hypertension
Diabetes Mellitus
 Drug: Benazepril
Drug: Losartan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between Losartan and Benazepril in Diabetic Hypertensive Patients With Blood Pressure Not Controlled by Amlodipine: Effects on Echocardiographic Parameters, Vascular Stiffness and Endothelial Function.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Universitario Pedro Ernesto:

Primary Outcome Measures:
  • Vascular stiffness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Vascular stiffness will be measured by pulse wave velocity and augmentation index and compared between groups (losartan and benazepril).

  • Endothelial function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Access endothelial function by peripheral arterial tonometry and brachial flow-mediated vasodilation and compare it between groups (losartan and benazepril).

  • Atrial size [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Access atrial size by echocardiogram and compare it between groups (losartan and benazepril).

  • Diastolic heart function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Access myocardial diastolic functino by echocardiogram and compare it between groups (losartan and benazepril).


Secondary Outcome Measures:
  • Adverse effects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Compare the incidence of adverse effects between groups.

  • Left ventricular mass [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Access left ventricular mass by echocardiogram and compare it between groups (losartan and benazepril).

  • Estimated glomerular filtration rate [ Time Frame: 12 weeks. ] [ Designated as safety issue: No ]
    Access estimated glomerular filtration rate by MDRD equation and compare it between groups (losartan and benazepril).

  • Microalbuminuria [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Compare microalbuminuria between groups.

  • Ambulatorial blood pressure monitoring [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Compare both groups effects on ambulatorial blood pressure monitoring.


Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Losartan
This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
 Drug: Losartan
Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.
Active Comparator: Benazepril
This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
 Drug: Benazepril
Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.

Detailed Description:

Hypertension and diabetes mellitus are important risk factors for cardiovascular morbidity and mortality. Endothelial dysfunction and vascular rigidity are two pathophysiological mechanisms that may explain this relationship. Recent publications showed that both ACEi (angiotensin converting enzyme inhibitor) and ARB (angiotensin receptor blocker) were capable of improving vascular stiffness and endothelial function, and that these effects occurred despite blood pressure reduction.

This study main objective is to assess if ARB (losartan) effects are different from ACEi (benazepril) in patients with diabetes mellitus type 2 and blood pressure not controlled by amlodipine.

Vascular stiffness and endothelial function will be measured by: pulse wave velocity, augmentation index, brachial artery flow-mediated vasodilation and peripheral arterial tonometry (EndoPat). Echocardiographic parameters, such as indexes of diastolic function, will also be measured.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatorial patients with age between 40 and 70 years-old.
  • Systemic arterial hypertension previously diagnosed and in use of two or less anti-hypertensive drugs in the preceding 4 weeks.
  • Type 2 diabetes mellitus in use of oral medication that were not changed in the preceding 4 weeks. Glycated hemoglobin A1c less than 9.0%.
  • Accepted the consent form.

Exclusion Criteria:

  • Office systolic blood pressure equal or more than 180 mmHg, with or without treatment
  • Office diastolic blood pressure equal or more than 110 mmHg, with or without treatment
  • Evidences of a secondary cause for hypertension
  • Glycated hemoglobin A1c > 9.0%
  • Insulin therapy
  • Chronic kidney disease stage 4 or 5 or in dialysis
  • Advanced target organ lesion, obtained by history or additional exams, and defined by: previous myocardial infarction, heart failure with ejection fraction less than 40%, cerebral vascular accident (ischemic or hemorrhagic), peripheral vascular disease (claudication or doppler with obstruction > 50% of vascular lumen), retinopathy with visual loss, symptomatic neuropathy.
  • Cardiac arrhythmias, except for ectopic beats
  • Any clinical or disabling condition that, in the opinion of the investigators, may confound or prejudice study results.
  • Severe mitral regurgitation.
  • Women in fertile age without contraceptive methods in use.
  • Breastfeeding women.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603940

Locations
Brazil
Hospital Universitario Pedro Ernesto
Rio de Janeiro, RJ, Brazil, 20551030
Sponsors and Collaborators
Hospital Universitario Pedro Ernesto
Investigators
Study Chair: Wille Oigman, MD, DSc. Hospital Universitario Pedro Ernesto
Study Director: Mario F Neves, MD, DSc. Hospital Universitario Pedro Ernesto
Principal Investigator: Ronaldo A Gismondi, MD, MSc. Hospital Universitario Pedro Ernesto
  More Information

No publications provided

Responsible Party: Ronaldo Altenburg Odebrecht Curi Gismondi, Investigator. Medical Doctor. Master of Sciences., Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier: NCT01603940     History of Changes
Other Study ID Numbers: CONTROL STUDY
Study First Received: May 20, 2012
Last Updated: May 22, 2012
Health Authority: Brazil: National Health Surveillance Agency
Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Universitario Pedro Ernesto:
Hypertension
Diabetes Mellitus
Vascular stiffness
Endothelial function

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Benazepril
Losartan
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 21, 2013