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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005469
Other study ID # 4914
Secondary ID P50HL044546
Status Completed
Phase N/A
First received May 25, 2000
Last updated May 12, 2016
Start date September 1990
Est. completion date November 1996

Study information

Verified date May 2000
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To examine a school-based population of children for maturational changes in blood pressure and cardiac structures.


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.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date November 1996
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (7)

Janz KF, Burns TL, Mahoney LT. Predictors of left ventricular mass and resting blood pressure in children: the Muscatine Study. Med Sci Sports Exerc. 1995 Jun;27(6):818-25. — View Citation

Janz KF, Mahoney LT. Three-year follow-up of changes in aerobic fitness during puberty: the Muscatine Study. Res Q Exerc Sport. 1997 Mar;68(1):1-9. — View Citation

Janz KF, Witt J, Mahoney LT. The stability of children's physical activity as measured by accelerometry and self-report. Med Sci Sports Exerc. 1995 Sep;27(9):1326-32. — View Citation

Lauer RM, Clarke WR, Mahoney LT, Witt J. Childhood predictors for high adult blood pressure. The Muscatine Study. Pediatr Clin North Am. 1993 Feb;40(1):23-40. — View Citation

Mahoney LT, Burns TL, Stanford W, Thompson BH, Witt JD, Rost CA, Lauer RM. Coronary risk factors measured in childhood and young adult life are associated with coronary artery calcification in young adults: the Muscatine Study. J Am Coll Cardiol. 1996 Feb;27(2):277-84. — View Citation

Mahoney LT, Clarke WR, Burns TL, Lauer RM. Childhood predictors of high blood pressure. Am J Hypertens. 1991 Nov;4(11):608S-610S. Review. — View Citation

Malcolm DD, Burns TL, Mahoney LT, Lauer RM. Factors affecting left ventricular mass in childhood: the Muscatine Study. Pediatrics. 1993 Nov;92(5):703-9. — View Citation

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