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| ID | Type | Description | Link |
|---|---|---|---|
| 05-13589 | Other Identifier | Creighton University Institutional Review Board |
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Clinical trials have yet to test the adequacy of HTN control in African Americans (AA) when both control and intervention groups are given free antihypertensive medications and are involved in usual versus intensive intervention strategies. Because of this, it has not yet been determined whether the method of prescribing antihypertensive medications according to JNC 7 guidelines is more, less, or equally as effective as prescribing antihypertensive medications and providing intensive behavioral and clinical interventions. Knowledge in this area of HTN treatment should better able medical and health practitioners to help their AA subjects control HTN. The BEAT Hypertension Clinic will evaluate this method of HTN control by proposing a program that will evaluate the difference in HTN control among subjects receiving usual care and free medications and subjects also receiving free medications, but additionally being treated in a clinic that operates in a more intensive manner in relationship to patient behavior modification, patient-clinician interactions, and physical and social environments. At the conclusion of the study, the BEAT Hypertension Clinic investigators will report findings and help to answer the question of whether medication alone or medication combined with intensive behavioral and clinical treatment is more effective in HTN control in the AA population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs). |
|
| Control | Active Comparator | No intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrochlorothiazide | Drug | Hydrochlorothiazide 25 mg tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving Blood Pressure Goals | Percentage of subjects who achieved JNC-VII defined blood pressure goals. | 3 month intervals |
| Measure | Description | Time Frame |
|---|---|---|
| New Onset Diabetes Mellitus | 3 month intervals |
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Inclusion Criteria:
Demographics: men or women of self-declared African-American heritage between 25 and 80 years of age residing in the Omaha, Nebraska metropolitan area
History of documented uncontrolled (treated or untreated) hypertension (HTN) as defined by JNC 7 guidelines
Study eligibility will be based on the subject's current blood pressure control based on the average of two seated blood pressure measurements at two consecutive clinic visits at least one week apart
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Syed Mohiuddin, MD | Creighton University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Creighton Community Health Center | Omaha | Nebraska | 68104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs). |
| FG001 | Control | No intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Subjects Achieving Blood Pressure Goals | Percentage of subjects who achieved JNC-VII defined blood pressure goals. | Posted | Number | percentage of participants | 3 month intervals |
|
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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 | Intervention | Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tammy Burns, PharmD, Research Manager | Creighton Cardiac Center | 402-280-4292 | TammyBurns@creighton.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006852 | Hydrochlorothiazide |
| D017706 | Lisinopril |
| C091365 | hydrochlorothiazide, lisinopril drug combination |
| D009543 | Nifedipine |
| D008790 | Metoprolol |
| D001262 | Atenolol |
| D000068756 | Valsartan |
| D017292 | Doxazosin |
| D003000 | Clonidine |
| D006830 | Hydralazine |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
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| Lisinopril |
| Drug |
Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet |
|
| Lisinopril and Hydrochlorothiazide | Drug | L 10 mg and H 12.5 mg tablets, L 20 mg and H 12.5 mg tablets, L 20 mg and H 25 mg tablets |
|
| Nifedipine XL | Drug | 30 mg extended release tablets, 60 mg extended release tablets |
|
| Metoprolol tartrate | Drug | 50 mg tablets & 100 mg tablets |
|
|
| Atenolol | Drug | 50 mg tablet |
|
| Valsartan | Drug | 80 mg tablets & 160 mg tablet |
|
| Doxazosin | Drug | 4 mg tablets |
|
| Clonidine | Drug | 0.2 mg tablets |
|
| Hydralazine | Drug | 50 mg tablets |
|
| Metoprolol succinate | Drug | 50 mg tablet & 100 mg tablet |
|
|
| Amlodipine | Drug | 5 mg tablets & 10 mg tablets |
|
|
| Control |
No intervention |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | New Onset Diabetes Mellitus | Not Posted | 3 month intervals |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Control | No intervention | 0 | 50 | 0 | 50 |
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| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000601 | Amino Acids, Essential |
| D011224 | Prazosin |
| D011799 | Quinazolines |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D010793 | Phthalazines |
| D011724 | Pyridazines |