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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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In this research study, the goal is to find out if a currently FDA-approved medication called Tekturna(Aliskiren) along with the addition of Vitamin D will lower blood pressure and improve heart function in the African American population. High blood pressure occurs earlier in life in African Americans, is more severe, and is associated with greater organ damage in relation to uncontrolled hypertension. Having low levels of Vitamin D is also very common in the African American population. Research has shown that there may be a link between low Vitamin D levels and the ability of high blood pressure medications to be fully effective.
The overarching hypothesis is that African Americans with hypertension have an overactive RAS (Renin Angiotensin System) in the body that is responsible for internally regulating blood pressure. Many blood pressure medications change regulation of the RAS system in order to keep blood pressure down. The purpose of this research study is to determine whether or not African American adults with hypertension have an overactive RAS system due to Vitamin D deficiency, resulting in the inability of the medication Tekturna to lower blood pressure. In this study, all participants will receive 300mg of Tekturna per day. Additionally half of the participants will randomly be selected to receive either 50,000 IU of Vitamin D (in its cholecalciferol form) orally once every other week or a vitamin D placebo once every other week. There will be 4 study visits over 18 weeks and follow up phone calls every two weeks for the duration of the study.
Specific Aims:
To demonstrate in African American Hypertensives consuming a calcium replete diet that Tekturna + Vitamin D will lower blood pressure more than Tekturna + placebo.
To demonstrate in African American hypertensives consuming a calcium replete diet that albuminuria will be lowered more with Tekturna + Vitamin D versus Tekturna + placebo.
To demonstrate in African American hypertensives consuming a calcium replete diet that Tekturna + Vitamin D will improve measures on non-invasively measured vascular function (peripheral vascular resistance, augmentation index, carotid-femoral pulse wave velocity and central aortic pressure) more than Tekturna + placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tekturna (Aliskirin) with vit. D supplementation | Active Comparator | Tekturna (Aliskiren) 300mg daily and vitamin D supplementation (50,000 IU)every other week. |
|
| Tekturna (Aliskiren) with placebo | Placebo Comparator | Tekturna (Aliskiren) 300mg per day supplemented with placebo (vitamin D) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D (cholecalciferol) | Dietary Supplement | Tekturna (Aliskirin) 300 mg per day supplemented with 50,000 IU Vitamin D every other week x 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ambulatory Systolic Blood Pressure | from baseline (Week 10) to Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ambulatory diastolic blood pressure | from baseline (Week 10) to Week 18 | |
| Change in cuff systolic blood pressure | from baseline (Week 10) to Week 18 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carol A Muzyk, CCRP | Contact | 313-745-2378 | cmuzyk@med.wayne.edu | |
| Donna Ford | Contact | 888-235-5467 |
| Name | Affiliation | Role |
|---|---|---|
| John M Flack, M.D., M.P.H. | Wayne State University, TRaCE Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University, 4201 St. Antoine | Recruiting | Detroit | Michigan | 48201 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| C446481 | aliskiren |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Tekturna(Aliskiren) plus placebo | Drug | Aliskiren 300 mg per day supplemented with placebo |
|
|
| Change in cuff diastolic blood pressure |
| from baseline (week 10) to Week 18 |
| Change in Urinary albumin:creatinine ratio | from baseline (week 10) to Week 18 |
| Change in plasma isoprostanes | from baseline (week 10) to Week 18 |
| Change in urinary nitric oxide metabolites | from baseline (week 10) to Week 18 |
| Change in plasma renin activity | from baseline (week 10) to Week 18 |
| Change in urinary angiotensinogen | from baseline (week 10) to Week 18 |
| Change in non-invasively obtained measures of vascular function | from baseline (week 10) to Week 18 |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |