Black Education and Treatment of Hypertension (BEAT HTN)

NCT00661895 | Completed Phase 4 Results

• 2 other identifiers: 05-1385905-13589
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

African American

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Achieving Blood Pressure Goals

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

  3 month intervals

Secondary Outcomes (1)

• New Onset Diabetes Mellitus

  3 month intervals

Study Arms (2)

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; 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

Control

ACTIVE COMPARATOR

No intervention

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

Interventions

Hydrochlorothiazide DRUG

Hydrochlorothiazide 25 mg tablets

Control; Intervention

Lisinopril DRUG

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

Control; Intervention

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

Control; Intervention

Nifedipine XL DRUG

30 mg extended release tablets, 60 mg extended release tablets

Control; Intervention

Metoprolol tartrate DRUG

50 mg tablets \& 100 mg tablets

Also known as: Lopressor

Control; Intervention

Atenolol DRUG

50 mg tablet

Control; Intervention

Valsartan DRUG

80 mg tablets \& 160 mg tablet

Control; Intervention

Doxazosin DRUG

4 mg tablets

Control; Intervention

Clonidine DRUG

0.2 mg tablets

Control; Intervention

Hydralazine DRUG

50 mg tablets

Control; Intervention

Metoprolol succinate DRUG

50 mg tablet \& 100 mg tablet

Also known as: Toprol XL

Control; Intervention

Amlodipine DRUG

5 mg tablets \& 10 mg tablets

Also known as: Norvasc

Control; Intervention

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton Community Health Center

Omaha, Nebraska, 68104, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Hydrochlorothiazide; Lisinopril; hydrochlorothiazide, lisinopril drug combination; Nifedipine; Metoprolol; Atenolol; Valsartan; Doxazosin; Clonidine; Hydralazine; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Tetrazoles; Azoles; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Essential; Prazosin; Quinazolines; Imidazolines; Imidazoles; Phthalazines; Pyridazines

Results Point of Contact

• Title: Tammy Burns, PharmD, Research Manager
• Organization: Creighton Cardiac Center

TammyBurns@creighton.edu

402-280-4292

Study Officials

• Syed Mohiuddin, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: April 21, 2008
• Study Start: August 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 4, 2012
• Results First Posted: December 4, 2012

Record last verified: 2012-11

Locations

US (1)