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Completed

NCT Number: NCT01603940

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

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

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario Pedro Ernesto

Rio de Janeiro, 20551030, Brazil

About this study

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-induced) 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 endothelial function in patients with diabetes mellitus type 2 and blood pressure not controlled by amlodipine and its relationship to statin current use.

Secondary analysis of vascular stiffness will be measured by pulse wave velocity and augmentation index. Echocardiographic parameters, such as indexes of diastolic function, will also be measured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Benazepril

Drug

Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.

Other names: Lotensin, 0078-0447-05

Losartan

Drug

Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.

Other names: Cozaar, 0006-0951-54

Primary outcomes

  1. Endothelial Function

    Time frame: 12 weeks

    Access endothelial function by brachial flow-mediated vasodilation (FMD) and compare it between groups (losartan and benazepril) and its relationship to current statin use.

Secondary outcomes

  1. Vascular Stiffness

    Time frame: 12 weeks.

    Access vascular stiffness by pulse wave velocity and compare it between groups (losartan and benazepril).

  2. Systolic Blood Pressure

    Time frame: 12 weeks

    Compare both groups effects on systolic blood pressure.

  3. Diastolic Blood Pressure

    Time frame: 12 weeks

    Compare both group effects on diastolic blood pressure.

  4. Vascular Stiffness by Augmentation Index

    Time frame: 12 weeks

    Estimate vascular stiffness by measuring augmentation index and compare it between losartan and benazepril groups.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Pedro Ernesto

Other

Registry information

Official study 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.

Acronym: CONTROL

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 23, 2012
Registry last updated
Feb 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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