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Black Education and Treatment of Hypertension (BEAT HTN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00661895
First received: December 28, 2007
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  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
Drug: Atenolol
Drug: Valsartan
Drug: Doxazosin
Drug: Clonidine
Drug: Hydralazine
Drug: Metoprolol succinate
Drug: Amlodipine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Black Education and Treatment of Hypertension (BEAT HTN)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Percentage of Subjects Achieving Blood Pressure Goals [ Time Frame: 3 month intervals ] [ Designated as safety issue: Yes ]
    Percentage of subjects who achieved JNC-VII defined blood pressure goals.


Secondary Outcome Measures:
  • New Onset Diabetes Mellitus [ Time Frame: 3 month intervals ] [ Designated as safety issue: Yes ]

Enrollment: 99
Study Start Date: August 2005
Study Completion Date: November 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Toprol XL
Drug: Amlodipine
5 mg tablets & 10 mg tablets
Other Name: 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 Name: 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 Name: Toprol XL
Drug: Amlodipine
5 mg tablets & 10 mg tablets
Other Name: Norvasc

  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

Locations
United States, Nebraska
Creighton Community Health Center
Omaha, Nebraska, United States, 68104
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Syed Mohiuddin, MD Creighton University
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00661895     History of Changes
Other Study ID Numbers: 05-13859, 05-13589
Study First Received: December 28, 2007
Results First Received: August 4, 2011
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
African American

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Atenolol
Metoprolol
Valsartan
Clonidine
Hydralazine
Hydrochlorothiazide
Amlodipine
Lisinopril
Doxazosin
Metoprolol succinate
Nifedipine
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-2 Receptor Agonists

ClinicalTrials.gov processed this record on May 19, 2013