Hypertension
Conditions
Keywords
African American
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.
Interventions
DRUGAmlodipine
5 mg tablets & 10 mg tablets
DRUGMetoprolol succinate
50 mg tablet & 100 mg tablet
DRUGHydrochlorothiazide
Hydrochlorothiazide 25 mg tablets
DRUGLisinopril
Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet
DRUGLisinopril 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
DRUGNifedipine XL
30 mg extended release tablets, 60 mg extended release tablets
50 mg tablets & 100 mg tablets
DRUGAtenolol
50 mg tablet
DRUGValsartan
80 mg tablets & 160 mg tablet
DRUGDoxazosin
4 mg tablets
DRUGClonidine
0.2 mg tablets
DRUGHydralazine
50 mg tablets
Sponsors
Creighton University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving Blood Pressure Goals | 3 month intervals | Percentage of subjects who achieved JNC-VII defined blood pressure goals. |
Secondary
| Measure | Time frame |
|---|---|
| New Onset Diabetes Mellitus | 3 month intervals |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 49 |
| Control No intervention | 50 |
| Total | 99 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 46 Participants | 93 Participants |
| Age Continuous | 50 years STANDARD_DEVIATION 11 | 49.6 years STANDARD_DEVIATION 9.81 | 49.8 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 50 participants | 49 participants | 99 participants |
| Sex: Female, Male Female | 39 Participants | 33 Participants | 72 Participants |
| Sex: Female, Male Male | 11 Participants | 16 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 50 |
| serious Total, serious adverse events | 0 / 49 | 0 / 50 |
Outcome results
Primary
Percentage of Subjects Achieving Blood Pressure Goals
Percentage of subjects who achieved JNC-VII defined blood pressure goals.
Time frame: 3 month intervals
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Percentage of Subjects Achieving Blood Pressure Goals | 81 percentage of participants |
| Control | Percentage of Subjects Achieving Blood Pressure Goals | 57 percentage of participants |
Secondary
New Onset Diabetes Mellitus
Time frame: 3 month intervals