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| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 29, 2000 |
| Last Updated Date | January 20, 2009 |
| Start Date ICMJE | June 1989 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00007592 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Hypertension Screening and Treatment Program |
| Official Title ICMJE | VA HYPERTENSION SCREENING AND TREATMENT PROGRAM (PILOT STUDY) |
| 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 Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Prospective |
| Condition ICMJE | Hypertension |
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Patients at Hypertension Screening and Treatment Program clinics |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States, Puerto Rico |
| Administrative Information | |
| NCT ID ICMJE | NCT00007592 |
| Responsible Party | |
| Study ID Numbers ICMJE | 324 |
| Study Sponsor ICMJE | Department of Veterans Affairs |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Department of Veterans Affairs |
| Verification Date | February 2003 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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