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End-organ Pathology in Childhood Essential Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005180
First Posted: May 26, 2000
Last Update Posted: February 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To determine the distribution of left ventricular hypertrophy and retinal vascular abnormalities in children and adolescents with essential hypertension; to evaluate potential risk factors and the time sequence for the development of these end-organ complications in this population.

Condition
Cardiovascular Diseases Heart Diseases Hypertension

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1985
Study Completion Date: June 1995
Detailed Description:

BACKGROUND:

Elevated blood pressure has been established as an important risk factor for the development of cardiovascular disease morbidity and mortality. The major manifestations of end-organ pathology associated with hypertension include congestive heart failure, ischemic heart disease, stroke, and peripheral artery disease, including renal failure and retinopathy. As blood pressure has been studied in children, it has become evident that adult essential hypertension and its complications may have origins in adolescence and childhood. Clinical observations have shown that some individuals with elevated blood pressure will develop one form of morbidity, while others develop a different form, and still others do not develop any complications. The reasons for this are unknown. Few studies have been done which attempt to delineate risk factors for the development of the different end-organ pathologies in hypertensive individuals. Two end-organ problems are particularly amenable to study in children. Ultrasound examination of the heart allows the non-invasive study of left ventricular hypertrophy which is an important precursor to the development of congestive heart failure. Retinal examination by fundal photograph and fluorescein angiography allows the examination of the effects of elevated blood pressure on the vessels of the eye.

DESIGN NARRATIVE:

The first phase of the study had a cross-sectional design. In this phase, echocardiography was used to measure left ventricular dimensions, mass, volume and function and fundoscopic examination and fluorescein angiography were used to determine retinal vascular abnormalities. Data were collected on the independent variables of age, sex, race, obesity, level and duration of increased blood pressure, ambulatory variability of blood pressure, family history of hypertension, treatment with antihypertensive medication, sodium intake, smoking, alcohol use, fasting blood glucose, hemoglobin, basal plasma renin activity, plasma catecholamines, cardiovascular reactions to mental stress and to exercise. Multiple regression analysis was used to determine which of the independent variables were independently associated with left ventricular mass, creatinine clearance, and retinal vascular abnormality.

The second phase of the study was a longitudinal investigation of the development of left ventricular hypertrophy, changes in left ventricular function and retinal vascular disease, and the temporal relationship of these complications to the risk factors found in the first phase, using a cohort design.

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005180     History of Changes
Other Study ID Numbers: 1058
R01HL034698 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: February 18, 2016
Last Verified: May 2000

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Heart Diseases
Vascular Diseases