Comparison Between Losartan and Benazepril in Diabetic Hypertensive Patients Not Controlled by Amlodipine (CONTROL)
|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.|
- Endothelial Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Access endothelial function by brachial flow-mediated vasodilation (FMD) and compare it between groups (losartan and benazepril) and its relationship to current statin use.
- Vascular Stiffness [ Time Frame: 12 weeks. ] [ Designated as safety issue: No ]Access vascular stiffness by pulse wave velocity and compare it between groups (losartan and benazepril).
- Systolic Blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Compare both groups effects on systolic blood pressure.
- Diastolic Blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Compare both group effects on diastolic blood pressure.
- Vascular Stiffness by Augmentation Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Estimate vascular stiffness by measuring augmentation index and compare it between losartan and benazepril groups.
|Study Start Date:||May 2012|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Losartan
This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
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.
Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603940
|Hospital Universitario Pedro Ernesto|
|Rio de Janeiro, RJ, Brazil, 20551030|
|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|