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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | September 1990 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005469 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Maturational Changes in Cardiac Structures -- Blood Pressure Relationship -- SCOR in Hypertension |
| Official Title ICMJE | |
| Brief Summary | To examine a school-based population of children for maturational changes in blood pressure and cardiac structures. |
| Detailed Description | BACKGROUND: Although excessive left ventricular mass has been viewed as an adaptation to increased blood pressure, it can precede the rise in blood pressure in hypertensive models. Excessive growth of the heart may reflect additional factors contributing to eventual level of blood pressure. In children, rapid heart growth may be predictive of subsequent high childhood blood pressure level and greater incidence of cardiovascular disease in adult relatives. These studies had the potential of defining maturational changes in known risk factors which might help predict future hypertensive disease. The study was a subproject within a Specialized Center of Research (SCOR) in Hypertension. The Request for Applications for the SCOR was released in October, 1988. DESIGN NARRATIVE: A total of 124 prepubertal males and females were followed longitudinally for five years. Yearly examinations defined the stages of sexual maturation. On four occasions each year, subjects were studied for resting and ambulatory blood pressure, echocardiography, anthropometry and activity assessment. Once yearly, each subject had blood drawn for hormone analyses and whole blood viscosity estimate. From these data, growth velocities of the heart and rate of change of blood pressure were determined. These parameters were analyzed to determine if rapid growth of the heart preceded or followed the rise in blood pressure observed during puberty and body size and composition, sexual maturation and hormone changes, and sympathetic activity. The study was a subproject within a SCOR in Hypertension. Approximately 7 percent of total dollars were awarded for this subproject. |
| 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 1996 |
| 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 | NCT00005469 |
| Responsible Party | |
| Study ID Numbers ICMJE | 4914 |
| 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 | May 2000 |
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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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