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

NCT ID: NCT01603940

Last Updated: 2016-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-01-31

Brief 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.

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-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.

Conditions

Hypertension; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Losartan

This group will receive 100 mg of losartan per day. Amlodipine will be maintained.

Group Type: ACTIVE_COMPARATOR

Losartan

Intervention Type: DRUG

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

Benazepril

This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.

Group Type: ACTIVE_COMPARATOR

Benazepril

Intervention Type: DRUG

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

Interventions

Benazepril

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

Intervention Type: DRUG

Losartan

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

Intervention Type: DRUG

Other Intervention Names

Lotensin; 0078-0447-05; Cozaar; 0006-0951-54

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Pedro Ernesto

OTHER

Sponsor Role: lead

Responsible Party

Ronaldo Altenburg Odebrecht Curi Gismondi

Investigator. Medical Doctor. Master of Sciences.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wille Oigman, MD, DSc.

Role: STUDY_CHAIR

Hospital Universitario Pedro Ernesto

Mario F Neves, MD, DSc.

Role: STUDY_DIRECTOR

Hospital Universitario Pedro Ernesto

Ronaldo A Gismondi, MD, MSc.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Pedro Ernesto

Locations

Hospital Universitario Pedro Ernesto

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

Gismondi RA, Bedirian R, Pozzobon CR, Ladeira MC, Oigman W, Neves MF. Renin-Angiotensin System Blockade Associated with Statin Improves Endothelial Function in Diabetics. Arq Bras Cardiol. 2015 Dec;105(6):597-605. doi: 10.5935/abc.20150123. Epub 2015 Oct 2.

Reference Type: DERIVED

PMID: 26465872 (View on PubMed)

Other Identifiers

CONTROL STUDY

Identifier Type: -

Identifier Source: org_study_id