Black Education and Treatment of Hypertension (BEAT HTN) - Full Text View

Sponsor:	Creighton University
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00661895

Purpose

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.

Condition	Intervention	Phase
Hypertension	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	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Black Education and Treatment of Hypertension (BEAT HTN)

Resource links provided by NLM:

Further study details as provided by Creighton University:

Primary Outcome Measures:

The primary study endpoint will be the percentage of subjects achieving blood pressure goals (< 140/90 mmHg for non-diabetic subjects and < 130/80 mmHg in diabetic subjects) in the usual care and intervention subject groups [ Time Frame: 3 month intervals ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

New onset diabetes mellitus [ Time Frame: 3 month intervals ] [ Designated as safety issue: Yes ]

Enrollment:	160
Study Start Date:	August 2005
Study Completion Date:	November 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intervention: Experimental 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).	Drug: Hydrochlorothiazide Hydrochlorothiazide 25 mg tablets Drug: Lisinopril Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet Drug: Lisinopril 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 Drug: Nifedipine XL 30 mg extended release tablets, 60 mg extended release tablets Drug: Metoprolol tartrate 50 mg tablets & 100 mg tablets Drug: Atenolol 50 mg tablet Drug: Valsartan 80 mg tablets & 160 mg tablet Drug: Doxazosin 4 mg tablets Drug: Clonidine 0.2 mg tablets Drug: Hydralazine 50 mg tablets Drug: Metoprolol succinate 50 mg tablet & 100 mg tablet Drug: Amlodipine 5 mg tablets & 10 mg tablets
Control: Active Comparator No intervention	Drug: Hydrochlorothiazide Hydrochlorothiazide 25 mg tablets Drug: Lisinopril Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet Drug: Lisinopril 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 Drug: Nifedipine XL 30 mg extended release tablets, 60 mg extended release tablets Drug: Metoprolol tartrate 50 mg tablets & 100 mg tablets Drug: Atenolol 50 mg tablet Drug: Valsartan 80 mg tablets & 160 mg tablet Drug: Doxazosin 4 mg tablets Drug: Clonidine 0.2 mg tablets Drug: Hydralazine 50 mg tablets Drug: Metoprolol succinate 50 mg tablet & 100 mg tablet Drug: Amlodipine 5 mg tablets & 10 mg tablets

Arms

Assigned Interventions

Intervention: Experimental

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).

Drug: Hydrochlorothiazide

Hydrochlorothiazide 25 mg tablets

Drug: Lisinopril

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

Drug: Lisinopril 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

Drug: Nifedipine XL

30 mg extended release tablets, 60 mg extended release tablets

Drug: Metoprolol tartrate

50 mg tablets & 100 mg tablets

Drug: Atenolol

50 mg tablet

Drug: Valsartan

80 mg tablets & 160 mg tablet

Drug: Doxazosin

4 mg tablets

Drug: Clonidine

0.2 mg tablets

Drug: Hydralazine

50 mg tablets

Drug: Metoprolol succinate

50 mg tablet & 100 mg tablet

Drug: Amlodipine

5 mg tablets & 10 mg tablets

Control: Active Comparator

No intervention

Drug: Hydrochlorothiazide

Hydrochlorothiazide 25 mg tablets

Drug: Lisinopril

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

Drug: Lisinopril 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

Drug: Nifedipine XL

30 mg extended release tablets, 60 mg extended release tablets

Drug: Metoprolol tartrate

50 mg tablets & 100 mg tablets

Drug: Atenolol

50 mg tablet

Drug: Valsartan

80 mg tablets & 160 mg tablet

Drug: Doxazosin

4 mg tablets

Drug: Clonidine

0.2 mg tablets

Drug: Hydralazine

50 mg tablets

Drug: Metoprolol succinate

50 mg tablet & 100 mg tablet

Drug: Amlodipine

5 mg tablets & 10 mg tablets

Eligibility

Ages Eligible for Study:	25 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661895

Locations

United States, Nebraska
Creighton Community Health Center
Omaha, Nebraska, United States, 68104

Sponsors and Collaborators

Creighton University

Investigators

Principal Investigator:

Syed Mohiuddin, MD

Creighton University

More Information

No publications provided

Responsible Party:	Creighton University ( Syed Mohiuddin, MD )
Study ID Numbers:	05-13859, 05-13589
Study First Received:	December 28, 2007
Last Updated:	November 27, 2009
ClinicalTrials.gov Identifier:	NCT00661895 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Creighton University:

African American

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Sodium Chloride Symporter Inhibitors
Diuretics
Hydralazine
Physiological Effects of Drugs
Calcium Channel Blockers
Reproductive Control Agents
Nifedipine
Adrenergic Agonists
Membrane Transport Modulators
Tocolytic Agents

Sensory System Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Adrenergic beta-Antagonists
Cardiovascular Diseases
Analgesics
Anti-Arrhythmia Agents
Valsartan
Sympatholytics
Adrenergic alpha-Agonists
Lisinopril
Clonidine
Vascular Diseases
Enzyme Inhibitors
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on February 08, 2010