Black Education and Treatment of Hypertension (BEAT HTN)

Phase 4

Completed

Conditions: Hypertension

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

Registration Number: NCT00661895

Lead Sponsor: Creighton University

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 99

Inclusion Criteria

Demographics: men or women of self-declared African-American heritage between 25 and 80 years of age residing in the Omaha, Nebraska metropolitan area
History of documented uncontrolled (treated or untreated) hypertension (HTN) as defined by JNC 7 guidelines
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

Myocardial infarction or stroke in the previous 6 months
Symptomatic heart failure or a left ventricular ejection fraction < 35%
Angina pectoris in the prior six months
Coronary revascularization procedure in the prior 6 months
Renal insufficiency defined as a serum creatinine > 2 mg/dl
Illicit drug or alcohol abuse in the prior 6 months
Dementia or other organic brain disease
Serious systemic illness with a shortened life expectancy or other limitation that precludes participation in this trial
Secondary HTN
Concurrent participation in an investigational medication trial

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Clonidine	No intervention
Intervention	Hydrochlorothiazide	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).
Intervention	Nifedipine XL	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).
Intervention	Clonidine	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).
Intervention	Hydralazine	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).
Intervention	Metoprolol succinate	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).
Control	Metoprolol tartrate	No intervention
Control	Nifedipine XL	No intervention
Control	Hydralazine	No intervention
Control	Metoprolol succinate	No intervention
Control	Atenolol	No intervention
Intervention	Lisinopril	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).
Intervention	Lisinopril and Hydrochlorothiazide	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).
Intervention	Metoprolol tartrate	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).
Intervention	Atenolol	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).
Intervention	Doxazosin	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).
Intervention	Valsartan	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).
Intervention	Amlodipine	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).
Control	Hydrochlorothiazide	No intervention
Control	Lisinopril	No intervention
Control	Valsartan	No intervention
Control	Lisinopril and Hydrochlorothiazide	No intervention
Control	Doxazosin	No intervention
Control	Amlodipine	No intervention