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Completed

NCT Number: NCT00661895

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Creighton Community Health Center

Omaha, Nebraska, 68104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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)

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

Treatment and study plan

Hydrochlorothiazide

Drug

Hydrochlorothiazide 25 mg tablets

Lisinopril

Drug

Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet

Lisinopril and Hydrochlorothiazide

Drug

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

Nifedipine XL

Drug

30 mg extended release tablets, 60 mg extended release tablets

Metoprolol tartrate

Drug

50 mg tablets & 100 mg tablets

Other names: Lopressor

Atenolol

Drug

50 mg tablet

valsartan

Drug

80 mg tablets & 160 mg tablet

Doxazosin

Drug

4 mg tablets

Clonidine

Drug

0.2 mg tablets

Hydralazine

Drug

50 mg tablets

Metoprolol succinate

Drug

50 mg tablet & 100 mg tablet

Other names: Toprol XL

Amlodipine

Drug

5 mg tablets & 10 mg tablets

Other names: Norvasc

Primary outcomes

  1. Percentage of Subjects Achieving Blood Pressure Goals

    Time frame: 3 month intervals

    Percentage of subjects who achieved JNC-VII defined blood pressure goals.

Secondary outcomes

  1. New Onset Diabetes Mellitus

    Time frame: 3 month intervals

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Acronym: BEAT

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Apr 21, 2008
Registry last updated
Dec 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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