Black Education and Treatment of Hypertension (BEAT HTN)

Study Overview
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Brief Summary
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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.

Official Title
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Black Education and Treatment of Hypertension (BEAT HTN)

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Hydrochlorothiazide
* Drug: Lisinopril
* Drug: Lisinopril and Hydrochlorothiazide
* Drug: Nifedipine XL
* Drug: Metoprolol tartrate
* Drug: Atenolol
* Drug: Valsartan
* Drug: Doxazosin
* Drug: Clonidine
* Drug: Hydralazine
* Drug: Metoprolol succinate
* Drug: Amlodipine


Participation Criteria
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Eligibility Criteria
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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 Untreated subjects with elevated blood pressure (> 140/90 mmHg or < 130/80 mmHg for diabetics) Subjects treated with antihypertensive therapy whose blood pressure does not meet current JNC 7 guidelines (< 140/90 mmHg for non-diabetics and < 130/80 mmHg for diabetics) Exclusion Criteria: Myocardial infarction or stroke in the previous 6 months Symptomatic heart failure or a left ventricular ejection fraction < 35% Angina pectoris in the prior six months Coronary revascularization procedure in the prior 6 months Renal insufficiency defined as a serum creatinine > 2 mg/dl Illicit drug or alcohol abuse in the prior 6 months Dementia or other organic brain disease Serious systemic illness with a shortened life expectancy or other limitation that precludes participation in this trial Secondary HTN Concurrent participation in an investigational medication trial

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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). | Drug: Hydrochlorothiazide<br>* Hydrochlorothiazide 25 mg tablets<br>Drug: Lisinopril<br>* Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet<br>Drug: Lisinopril and Hydrochlorothiazide<br>* 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<br>Drug: Nifedipine XL<br>* 30 mg extended release tablets, 60 mg extended release tablets<br>Drug: Metoprolol tartrate<br>* 50 mg tablets & 100 mg tablets<br>* Other names: Lopressor;Drug: Atenolol<br>* 50 mg tablet<br>Drug: Valsartan<br>* 80 mg tablets & 160 mg tablet<br>Drug: Doxazosin<br>* 4 mg tablets<br>Drug: Clonidine<br>* 0.2 mg tablets<br>Drug: Hydralazine<br>* 50 mg tablets<br>Drug: Metoprolol succinate<br>* 50 mg tablet & 100 mg tablet<br>* Other names: Toprol XL;Drug: Amlodipine<br>* 5 mg tablets & 10 mg tablets<br>* Other names: Norvasc;|
| Active Comparator: Control<br>No intervention | Drug: Hydrochlorothiazide<br>* Hydrochlorothiazide 25 mg tablets<br>Drug: Lisinopril<br>* Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet<br>Drug: Lisinopril and Hydrochlorothiazide<br>* 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<br>Drug: Nifedipine XL<br>* 30 mg extended release tablets, 60 mg extended release tablets<br>Drug: Metoprolol tartrate<br>* 50 mg tablets & 100 mg tablets<br>* Other names: Lopressor;Drug: Atenolol<br>* 50 mg tablet<br>Drug: Valsartan<br>* 80 mg tablets & 160 mg tablet<br>Drug: Doxazosin<br>* 4 mg tablets<br>Drug: Clonidine<br>* 0.2 mg tablets<br>Drug: Hydralazine<br>* 50 mg tablets<br>Drug: Metoprolol succinate<br>* 50 mg tablet & 100 mg tablet<br>* Other names: Toprol XL;Drug: Amlodipine<br>* 5 mg tablets & 10 mg tablets<br>* Other names: Norvasc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Onset Diabetes Mellitus |  | 3 month intervals | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African American