Black Education and Treatment of Hypertension (BEAT HTN)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Achieving Blood Pressure Goals
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Untreated subjects with elevated blood pressure (> 140/90 mmHg or < 130/80 mmHg for diabetics)
- •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)
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Hydrochlorothiazide (Drug)
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).
干预措施: Lisinopril (Drug)
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).
干预措施: Lisinopril and Hydrochlorothiazide (Drug)
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).
干预措施: Nifedipine XL (Drug)
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).
干预措施: Metoprolol tartrate (Drug)
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).
干预措施: Atenolol (Drug)
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).
干预措施: Valsartan (Drug)
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).
干预措施: Doxazosin (Drug)
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).
干预措施: Clonidine (Drug)
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).
干预措施: Hydralazine (Drug)
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).
干预措施: Metoprolol succinate (Drug)
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).
干预措施: Amlodipine (Drug)
Control
No intervention
干预措施: Hydrochlorothiazide (Drug)
Control
No intervention
干预措施: Lisinopril (Drug)
Control
No intervention
干预措施: Lisinopril and Hydrochlorothiazide (Drug)
Control
No intervention
干预措施: Nifedipine XL (Drug)
Control
No intervention
干预措施: Metoprolol tartrate (Drug)
Control
No intervention
干预措施: Atenolol (Drug)
Control
No intervention
干预措施: Valsartan (Drug)
Control
No intervention
干预措施: Doxazosin (Drug)
Control
No intervention
干预措施: Clonidine (Drug)
Control
No intervention
干预措施: Hydralazine (Drug)
Control
No intervention
干预措施: Metoprolol succinate (Drug)
Control
No intervention
干预措施: Amlodipine (Drug)
结局指标
主要结局
Percentage of Subjects Achieving Blood Pressure Goals
时间窗: 3 month intervals
Percentage of subjects who achieved JNC-VII defined blood pressure goals.
次要结局
- New Onset Diabetes Mellitus(3 month intervals)