Black Education and Treatment of Hypertension (BEAT HTN)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Hydrochlorothiazide; Lisinopril; Lisinopril and Hydrochlorothiazide; Nifedipine XL; Metoprolol tartrate; Atenolol; Valsartan; Doxazosin; Clonidine; Hydralazine; Metoprolol succinate; Amlodipine
Intervention description: Hydrochlorothiazide 25 mg tablets; Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet; 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; 30 mg extended release tablets, 60 mg extended release tablets; 50 mg tablets & 100 mg tablets; 50 mg tablet; 80 mg tablets & 160 mg tablet; 4 mg tablets; 0.2 mg tablets; 50 mg tablets; 50 mg tablet & 100 mg tablet; 5 mg tablets & 10 mg tablets
Intervention MeSH terms: Metoprolol; Atenolol; Amlodipine; Valsartan; Hydrochlorothiazide; Clonidine; Lisinopril; Doxazosin; Hydralazine; Nifedipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 25 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: African American

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Demographics: men or women of self-declared African-American heritage between 25 and
             80 years of age residing in the Omaha, Nebraska metropolitan area

          2. History of documented uncontrolled (treated or untreated) hypertension (HTN) as
             defined by JNC 7 guidelines

          3. 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

               1. Untreated subjects with elevated blood pressure (> 140/90 mmHg or < 130/80 mmHg
                  for diabetics)

               2. 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:

          1. Myocardial infarction or stroke in the previous 6 months

          2. Symptomatic heart failure or a left ventricular ejection fraction < 35%

          3. Angina pectoris in the prior six months

          4. Coronary revascularization procedure in the prior 6 months

          5. Renal insufficiency defined as a serum creatinine > 2 mg/dl

          6. Illicit drug or alcohol abuse in the prior 6 months

          7. Dementia or other organic brain disease

          8. Serious systemic illness with a shortened life expectancy or other limitation that
             precludes participation in this trial

          9. Secondary HTN

         10. Concurrent participation in an investigational medication trial