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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Drug: Hydrochlorothiazide
  • Hydrochlorothiazide 25 mg tablets
• Drug: Lisinopril
  • Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet
• Drug: Lisinopril and Hydrochlorothiazide
  • 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
• Drug: Nifedipine XL
  • 30 mg extended release tablets, 60 mg extended release tablets
• Drug: Metoprolol tartrate (Lopressor)
  • 50 mg tablets & 100 mg tablets
• Drug: Atenolol
  • 50 mg tablet
• Drug: Valsartan
  • 80 mg tablets & 160 mg tablet
• Drug: Doxazosin
  • 4 mg tablets
• Drug: Clonidine
  • 0.2 mg tablets
• Drug: Hydralazine
  • 50 mg tablets
• Drug: Metoprolol succinate (Toprol XL)
  • 50 mg tablet & 100 mg tablet
• Drug: Amlodipine (Norvasc)
  • 5 mg tablets & 10 mg tablets

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• The primary study endpoint will be the percentage of subjects achieving blood pressure goals (< 140/90 mmHg for non-diabetic subjects and < 130/80 mmHg in diabetic subjects) in the usual care and intervention subject groups
  • Time Frame: 3 month intervals
    Safety Issue?: Yes

Secondary Measures

• New onset diabetes mellitus
  • Time Frame: 3 month intervals
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Creighton University

Overall Clinical Trial Officials and Contacts

Syed Mohiuddin, MD Principal Investigator Creighton University  

Overall Contact: Syed Mohiuddin, MD 402-280-4570 smm@creighton.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00661895

Study ID Number: 05-13859

ClinicalTrials.gov Identifier: NCT00661895

Health Authority: United States: Institutional Review Board