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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan | Active Comparator | This group will receive 100 mg of losartan per day. Amlodipine will be maintained. |
|
| Benazepril | Active Comparator | This group will receive 20 mg of benazepril per day. Amlodipine will be maintained. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benazepril | Drug | Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular Stiffness | Access vascular stiffness by pulse wave velocity and compare it between groups (losartan and benazepril). | 12 weeks. |
| Systolic Blood Pressure | Compare both groups effects on systolic blood pressure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wille Oigman, MD, DSc. | Hospital Universitario Pedro Ernesto | Study Chair |
| Mario F Neves, MD, DSc. | Hospital Universitario Pedro Ernesto | Study Director |
| Ronaldo A Gismondi, MD, MSc. | Hospital Universitario Pedro Ernesto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Pedro Ernesto | Rio de Janeiro | Rio de Janeiro | 20551030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26465872 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan | This group will receive 100 mg of losartan per day. Amlodipine will be maintained. Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks. |
| FG001 | Benazepril | This group will receive 20 mg of benazepril per day. Amlodipine will be maintained. Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Losartan | This group will receive 100 mg of losartan per day. Amlodipine will be maintained. Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks. |
| BG001 | Benazepril |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | percentage of maximal vasodilation | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Losartan | This group will receive 100 mg of losartan per day. Amlodipine will be maintained. Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema | Blood and lymphatic system disorders | edema | Systematic Assessment | Not severe edema in losartan group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronaldo Altenburg Gismondi, MD, PhD | Hospital Universitario Pedro Ernesto (UERJ) | +5521996092383 | ronaldogismondi@gmail.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C044946 | benazepril |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Losartan | Drug | Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks. |
|
|
| 12 weeks |
| Diastolic Blood Pressure | Compare both group effects on diastolic blood pressure. | 12 weeks |
| Vascular Stiffness by Augmentation Index | Estimate vascular stiffness by measuring augmentation index and compare it between losartan and benazepril groups. | 12 weeks |
This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Vascular Stiffness | Access vascular stiffness by pulse wave velocity and compare it between groups (losartan and benazepril). | Posted | Median | Inter-Quartile Range | m/s | 12 weeks. |
|
|
|
|
| Secondary | Systolic Blood Pressure | Compare both groups effects on systolic blood pressure. | Posted | Median | Inter-Quartile Range | mmHg | 12 weeks |
|
|
|
|
| Secondary | Diastolic Blood Pressure | Compare both group effects on diastolic blood pressure. | Posted | Median | Inter-Quartile Range | mmHg | 12 weeks |
|
|
|
| Secondary | Vascular Stiffness by Augmentation Index | Estimate vascular stiffness by measuring augmentation index and compare it between losartan and benazepril groups. | Posted | Median | Inter-Quartile Range | percentage of augmentation pressure | 12 weeks |
|
|
|
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | Benazepril | This group will receive 20 mg of benazepril per day. Amlodipine will be maintained. Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks. | 0 | 14 | 1 | 14 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | cough | Systematic Assessment | Cough due to benazepril (ACEi: angiotensin-converting enzyme inhibitor-induced) |
|
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| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |