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End-organ Pathology in Childhood Essential Hypertension

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypertension

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005180
    Brief Title
    End-organ Pathology in Childhood Essential Hypertension
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1985 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 1995 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Hypertension

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    8917226
    Citation
    Morrison JA, Alfaro MP, Khoury P, Thornton BB, Daniels SR. Determinants of resting energy expenditure in young black girls and young white girls. J Pediatr. 1996 Nov;129(5):637-42. doi: 10.1016/s0022-3476(96)70142-7.
    Results Reference
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    PubMed Identifier
    8675261
    Citation
    Daniels SR, Kimball TR, Khoury P, Witt S, Morrison JA. Correlates of the hemodynamic determinants of blood pressure. Hypertension. 1996 Jul;28(1):37-41. doi: 10.1161/01.hyp.28.1.37.
    Results Reference
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    PubMed Identifier
    3625408
    Citation
    Daniels SR, Loggie JM, Burton T, Kaplan S. Difficulties with ambulatory blood pressure monitoring in children and adolescents. J Pediatr. 1987 Sep;111(3):397-400. doi: 10.1016/s0022-3476(87)80462-6. No abstract available.
    Results Reference
    background
    PubMed Identifier
    3403828
    Citation
    Daniels SR, Meyer RA, Liang YC, Bove KE. Echocardiographically determined left ventricular mass index in normal children, adolescents and young adults. J Am Coll Cardiol. 1988 Sep;12(3):703-8. doi: 10.1016/s0735-1097(88)80060-3.
    Results Reference
    background
    PubMed Identifier
    2140133
    Citation
    Daniels SR, Meyer RA, Strife CF, Lipman M, Loggie JM. Distribution of target-organ abnormalities by race and sex in children with essential hypertension. J Hum Hypertens. 1990 Apr;4(2):103-4.
    Results Reference
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    PubMed Identifier
    1992741
    Citation
    Daniels SR, Lipman MJ, Burke MJ, Loggie JM. The prevalence of retinal vascular abnormalities in children and adolescents with essential hypertension. Am J Ophthalmol. 1991 Feb 15;111(2):205-8. doi: 10.1016/s0002-9394(14)72260-3.
    Results Reference
    background
    PubMed Identifier
    7586311
    Citation
    Daniels SR, Kimball TR, Morrison JA, Khoury P, Witt S, Meyer RA. Effect of lean body mass, fat mass, blood pressure, and sexual maturation on left ventricular mass in children and adolescents. Statistical, biological, and clinical significance. Circulation. 1995 Dec 1;92(11):3249-54. doi: 10.1161/01.cir.92.11.3249.
    Results Reference
    background
    PubMed Identifier
    7572628
    Citation
    Daniels SR, Kimball TR, Morrison JA, Khoury P, Meyer RA. Indexing left ventricular mass to account for differences in body size in children and adolescents without cardiovascular disease. Am J Cardiol. 1995 Oct 1;76(10):699-701. doi: 10.1016/s0002-9149(99)80200-8.
    Results Reference
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    PubMed Identifier
    8345488
    Citation
    Daniels SR, Lipman MJ, Burke MJ, Loggie JM. Determinants of retinal vascular abnormalities in children and adolescents with essential hypertension. J Hum Hypertens. 1993 Jun;7(3):223-8.
    Results Reference
    background
    PubMed Identifier
    8501551
    Citation
    Daniels SR, Strife CF, Dolan LM, Loggie JM. Distribution and correlates of creatinine clearance in children and adolescents with blood pressure elevation. J Pediatr. 1993 Jun;122(6):S68-73. doi: 10.1016/s0022-3476(09)90046-4.
    Results Reference
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    PubMed Identifier
    8450171
    Citation
    Kimball TR, Daniels SR, Loggie JM, Khoury P, Meyer RA. Relation of left ventricular mass, preload, afterload and contractility in pediatric patients with essential hypertension. J Am Coll Cardiol. 1993 Mar 15;21(4):997-1001. doi: 10.1016/0735-1097(93)90359-9.
    Results Reference
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    PubMed Identifier
    9609083
    Citation
    Daniels SR, Loggie JM, Khoury P, Kimball TR. Left ventricular geometry and severe left ventricular hypertrophy in children and adolescents with essential hypertension. Circulation. 1998 May 19;97(19):1907-11. doi: 10.1161/01.cir.97.19.1907.
    Results Reference
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    PubMed Identifier
    9672509
    Citation
    Young LA, Kimball TR, Daniels SR, Standiford DA, Khoury PR, Eichelberger SM, Dolan LM. Nocturnal blood pressure in young patients with insulin-dependent diabetes mellitus: correlation with cardiac function. J Pediatr. 1998 Jul;133(1):46-50. doi: 10.1016/s0022-3476(98)70176-3.
    Results Reference
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    PubMed Identifier
    10824731
    Citation
    de Simone G, Kimball TR, Roman MJ, Daniels SR, Celentano A, Witt SA, Devereux RB. Relation of left ventricular chamber and midwall function to age in normal children, adolescents and adults. Ital Heart J. 2000 Apr;1(4):295-300. Erratum In: Ital Heart J 2000 Sep;1(9):640.
    Results Reference
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    End-organ Pathology in Childhood Essential Hypertension

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