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Black Education and Treatment of Hypertension (BEAT HTN)
This study is currently recruiting participants.
Study NCT00661895   Information provided by Creighton University
First Received: December 28, 2007   Last Updated: April 16, 2009   History of Changes

December 28, 2007
April 16, 2009
August 2005
August 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00661895 on ClinicalTrials.gov Archive Site
New onset diabetes mellitus [ Time Frame: 3 month intervals ] [ Designated as safety issue: Yes ]
Same as current
 
Black Education and Treatment of Hypertension (BEAT HTN)
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.

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
300
 
August 2009   (final data collection date for primary outcome measure)

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
Both
25 Years to 80 Years
No
Contact: Syed Mohiuddin, MD 402-280-4570 smm@creighton.edu
United States
 
NCT00661895
Syed Mohiuddin, MD, Creighton University
05-13859, 05-13589
Creighton University
 
Principal Investigator: Syed Mohiuddin, MD Creighton University
Creighton University
April 2009

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