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

Hypertension Clinical Trial

— CONTROL  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603940
• Other study ID #: CONTROL STUDY
• Status: Completed
• Phase: Phase 4
• First received: May 20, 2012
• Last updated: December 29, 2015
• Start date: May 2012
• Est. completion date: January 2015

Study information

• Verified date: December 2015
• Source: Hospital Universitario Pedro Ernesto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance AgencyBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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-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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertension

Intervention

Drug:
• Benazepril
Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
• Losartan
Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.

Locations

Country	Name	City	State
Brazil	Hospital Universitario Pedro Ernesto	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Pedro Ernesto

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function	Access endothelial function by brachial flow-mediated vasodilation (FMD) and compare it between groups (losartan and benazepril) and its relationship to current statin use.	12 weeks	No
Secondary	Vascular Stiffness	Access vascular stiffness by pulse wave velocity and compare it between groups (losartan and benazepril).	12 weeks.	No
Secondary	Systolic Blood Pressure	Compare both groups effects on systolic blood pressure.	12 weeks	No
Secondary	Diastolic Blood Pressure	Compare both group effects on diastolic blood pressure.	12 weeks	No
Secondary	Vascular Stiffness by Augmentation Index	Estimate vascular stiffness by measuring augmentation index and compare it between losartan and benazepril groups.	12 weeks	No