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

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 Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68104
      • Creighton Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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; 50 mg tablets & 100 mg tablets; Other Names: Lopressor; 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; 50 mg tablet & 100 mg tablet; Other Names: Toprol XL; Drug: Amlodipine; 5 mg tablets & 10 mg tablets; Other Names: Norvasc
Active Comparator: Control; No intervention	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; 50 mg tablets & 100 mg tablets; Other Names: Lopressor; 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; 50 mg tablet & 100 mg tablet; Other Names: Toprol XL; Drug: Amlodipine; 5 mg tablets & 10 mg tablets; Other Names: Norvasc

What is the study measuring?

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	Time Frame
New Onset Diabetes Mellitus	3 month intervals

Collaborators and Investigators

• Sponsor: Creighton University
• Investigators: Principal Investigator: Syed Mohiuddin, MD, Creighton University

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: December 28, 2007
• First Submitted That Met QC Criteria: April 17, 2008
• First Posted (Estimate): April 21, 2008

Study Record Updates

• Last Update Posted (Estimate): December 4, 2012
• Last Update Submitted That Met QC Criteria: November 6, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: African American
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Protease Inhibitors; Protective Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Natriuretic Agents; Cardiotonic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Tocolytic Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Amlodipine; Valsartan; Hydrochlorothiazide; Metoprolol; Nifedipine; Clonidine; Lisinopril; Doxazosin; Atenolol; Hydralazine
• Other Study ID Numbers: 05-13859; 05-13589 (Other Identifier: Creighton University Institutional Review Board)