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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00661895
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
Creighton University

Tracking Information
First Submitted Date  ICMJE December 28, 2007
First Posted Date  ICMJE April 21, 2008
Results First Submitted Date  ICMJE August 4, 2011
Results First Posted Date  ICMJE December 4, 2012
Last Update Posted Date December 4, 2012
Study Start Date  ICMJE August 2005
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2012)
Percentage of Subjects Achieving Blood Pressure Goals [ Time Frame: 3 month intervals ]
Percentage of subjects who achieved JNC-VII defined blood pressure goals.
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2008)
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 ]
Change History Complete list of historical versions of study NCT00661895 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2008)
New Onset Diabetes Mellitus [ Time Frame: 3 month intervals ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Black Education and Treatment of Hypertension (BEAT HTN)
Official Title  ICMJE Black Education and Treatment of Hypertension (BEAT HTN)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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).
    Interventions:
    • 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
  • Active Comparator: Control
    No intervention
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2012)
99
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2008)
300
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00661895
Other Study ID Numbers  ICMJE 05-13859
05-13589 ( Other Identifier: Creighton University Institutional Review Board )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Creighton University
Study Sponsor  ICMJE Creighton University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Syed Mohiuddin, MD Creighton University
PRS Account Creighton University
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP