Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00007592 |
| Other study ID # |
324 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
December 29, 2000 |
| Last updated |
January 20, 2009 |
| Start date |
June 1989 |
Study information
| Verified date |
February 2003 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial 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.
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.
