Black Education and Treatment of Hypertension (BEAT HTN)

Creighton University

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Doxazosin; Drug: Metoprolol succinate; Drug: Amlodipine; Drug: Lisinopril; Drug: Hydralazine; Drug: Lisinopril and Hydrochlorothiazide; Drug: Metoprolol tartrate; Drug: Atenolol; Drug: Valsartan; Drug: Nifedipine XL; Drug: Hydrochlorothiazide; Drug: Clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT00661895

05-13589 (Other Identifier)

05-13859

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Intervention

Experimental group

Description:

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).

Treatment:

Drug: Amlodipine

Drug: Lisinopril

Drug: Atenolol

Drug: Valsartan

Drug: Nifedipine XL

Drug: Metoprolol tartrate

Drug: Metoprolol succinate

Drug: Hydrochlorothiazide

Drug: Clonidine

Drug: Hydralazine

Drug: Lisinopril and Hydrochlorothiazide

Drug: Doxazosin

Control

Active Comparator group

Description:

No intervention

Treatment:

Drug: Amlodipine

Drug: Lisinopril

Drug: Atenolol

Drug: Valsartan

Drug: Nifedipine XL

Drug: Metoprolol tartrate

Drug: Metoprolol succinate

Drug: Hydrochlorothiazide

Drug: Clonidine

Drug: Hydralazine

Drug: Lisinopril and Hydrochlorothiazide

Drug: Doxazosin