Viewing Study NCT00007592


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Study NCT ID: NCT00007592
Status: COMPLETED
Last Update Posted: 2009-01-21
First Post: 2000-12-29
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Hypertension Screening and Treatment Program
Sponsor: US Department of Veterans Affairs
Organization:

Study Overview

Official Title: VA HYPERTENSION SCREENING AND TREATMENT PROGRAM (PILOT STUDY)
Status: COMPLETED
Status Verified Date: 2003-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
Detailed Description: Primary Hypothesis: A variety of clinical questions of major importance can be addressed using clinical data routinely obtained in the VA Hypertension Screening and Treatment Program. For example, treatment of mild hypertension reduces the risk of strokes and heart attacks.

Secondary Hypothesis: Target organ damage occurs despite blood pressure control.

Intervention: Chlorthalidone, furosemide, hydrochlorothiazide, metolazone, indapamide, amiloride, spironolactone, triamterene, atenolol, metoprolol, nadolol, pindolol, propranolol, timolol, acebutolol, penbutolol, clonidine, guanethidine, methydopa, prazosin, guanadrel, labetalol, reserpine, guanfacine, hydralazine, minoxidil, captopril, enalapril, lisinopril, diltiazem, nifedipine, verapamil, nicardipine, dyazide, maxzide, pargyline, terazosin, other anti-hypertensives.

Primary Outcomes: Blood Pressure and Target Organ Damage

Study Abstract: Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.

This demonstration project provides for central collection of a standard set of clinical data for patients at some of the Hypertension Screening and Treatment Program clinics, thereby setting up a national data base on the treatment of hypertension. The primary objective of this project is to demonstrate the value of establishing this type of database. The database is being used to estimate the average annual cost of different antihypertensive regimens, to determine the cost-efficacy of different therapies and the least expensive effective therapy and to address some major unanswered clinical questions that require large populations and long-term patient care data. There are currently 13 medical centers participating.

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: