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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | December 1985 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005316 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | White Coat Hypertension and Antihypertensive Treatment Effect - SCOR in Hypertension |
| Official Title ICMJE | |
| Brief Summary | To investigate the mechanisms of white coat hypertension and study it further as a risk factor for heart damage. |
| Detailed Description | BACKGROUND: The multidisciplinary SCOR examined causes, consequences, and treatments of human hypertension. A central theme was the renal basis for human hypertension. The subproject on white coat hypertension began in December of 1985. DESIGN NARRATIVE: In the longitudinal study, eighty patients with white coat hypertension were compared with 40 age- and sex-matched normotensives, and with 80 patients with sustained hypertension. The protocol consisted of (a) clinic blood pressure measurements made both by a physician and a nurse, (b) self-monitoring at home, (c) noninvasive ambulatory monitoring, (d) reactivity testing (cold pressor test, mental arithmetic, and isometric exercise) and (e) Korotkoff signal recording. Patients were also tested for early markers of disease (echocardiography and urine albumin). The 80 patients in each of the two hypertensive groups were randomized to one of four treatment protocols (20 patients each); an alpha blocker, a beta blocker, a combined alpha- and beta-blocker, or an ACE inhibitor. The doses of medication were adjusted to produce similar reductions of clinic blood pressure in the different groups. The test battery (a-e) was reported during treatment. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Natural History, Longitudinal |
| Condition ICMJE |
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| Intervention ICMJE | |
| 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 | November 1995 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Male |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00005316 |
| Responsible Party | |
| Study ID Numbers ICMJE | 4086 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | August 2001 |
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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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