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Black Education and Treatment of Hypertension (BEAT HTN)
This study is currently recruiting participants.
Verified by Creighton University, July 2008
Sponsored by: Creighton University
Information provided by: Creighton University
ClinicalTrials.gov Identifier: NCT00661895
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Hydrochlorothiazide
Drug: Lisinopril
Drug: Lisinopril and Hydrochlorothiazide
Drug: Nifedipine XL
Drug: Metoprolol tartrate (Lopressor)
Drug: Atenolol
Drug: Valsartan
Drug: Doxazosin
Drug: Clonidine
Drug: Hydralazine
Drug: Metoprolol succinate (Toprol XL)
Drug: Amlodipine (Norvasc)
Phase IV

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Metoprolol Metoprolol fumarate Metoprolol succinate Metoprolol Tartrate Lisinopril Valsartan Nifedipine Succinic acid Clonidine Hydrochlorothiazide Doxazosin Doxazosin mesylate Atenolol Amlodipine Amlodipine besylate Clonidine hydrochloride Hydralazine Hydralazine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Black Education and Treatment of Hypertension (BEAT HTN)

Further study details as provided by Creighton University:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • New onset diabetes mellitus [ Time Frame: 3 month intervals ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: August 2005
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental 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
2: Active Comparator 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

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661895

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

Locations
United States, Nebraska
Creighton Community Health Center Recruiting
Omaha, Nebraska, United States, 68104
Contact: Stephanie Maciejewski, PharmD     402-280-4292     smacieje@cardiac.creighton.edu    
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Syed Mohiuddin, MD Creighton University
  More Information

Responsible Party: Creighton University ( Syed Mohiuddin, MD )
Study ID Numbers: 05-13859, 05-13589
Study First Received: December 28, 2007
Last Updated: July 24, 2008
ClinicalTrials.gov Identifier: NCT00661895  
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
African American

Study placed in the following topic categories:
Lisinopril
Clonidine
Hydralazine
Vascular Diseases
Metoprolol
Nifedipine
Hydrochlorothiazide
Doxazosin
Amlodipine
Calcium, Dietary
Metoprolol succinate
Atenolol
Valsartan
Hypertension

Additional relevant MeSH terms:
Neurotransmitter Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Cardiotonic Agents
Physiological Effects of Drugs
Diuretics
Sodium Chloride Symporter Inhibitors
Calcium Channel Blockers
Reproductive Control Agents
Membrane Transport Modulators
Tocolytic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Anti-Arrhythmia Agents
Sympatholytics
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Protease Inhibitors
Autonomic Agents
Natriuretic Agents
Adrenergic Antagonists
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009