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Hypertension in Blacks of West African Origin

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
    July 28, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005340
    Brief Title
    Hypertension in Blacks of West African Origin
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1991 (undefined)
    Primary Completion Date
    August 2005 (Actual)
    Study Completion Date
    August 2005 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To continue an international collaborative study on hypertension in populations of West African origin.
    Detailed Description
    BACKGROUND: The increased risk of hypertension in United States Blacks remains a major unsolved public health problem. Comparisons between macro-population groups in the United States suffer from confounding by social factors and genetic admixture. The study's international comparative design provides a unique opportunity to ascertain the evolution of hypertension among populations with a common genetic background currently living in widely varied social conditions. A well-organized network of investigators currently exists in the societies of the Black diaspora and provides for the first time an opportunity to conduct cross-national research on this question. DESIGN NARRATIVE: During the first phase of the project over 12,000 adults between the ages of 25 and 74 were sampled from seven communities: West Africa (Nigeria, urban & rural; Cameroon, urban & rural), the West Indies (St. Lucia, Barbados) and Maywood (lllinois). The screening examination provided information on blood pressure (BP), height, weight, waist/hip ratio, alcohol use, education/occupation, sodium/potassium excretion and social stress. These data provided estimates of hypertension prevalence in each geographic region and the contribution of the known risk factor to higher rates among United States Blacks. In the first phase considerable effort was directed toward establishing a strong research infrastructure in each of the sites and demonstrating the feasibility of cross-national blood pressure comparisons. In the second phase the research was continued and extended in three areas: 1) Population studies on risk factors. At the start of the study in 1991, it was not clear that adequate procedures were available to allow standardization of mean blood pressure across sites, especially since differences between some sites might be as little as 2 mmHg. Experience since that time suggested that it would be feasible to collect definitive data on this question. In-depth studies were carried out at one of the African sites to investigate the earliest stages of hypertension risk for a population. Investigators in Jamaica and the United Kingdom joined the collaborative group to examine the effect of migration from the Caribbean to the United Kingdom. 2) Prospective study of blood pressure and mortality. It was well known that hypertension accounted for much of the excess mortality among United States Blacks. It was less well recognized, however, that death rates among Blacks in the United States were higher than reported in the Caribbean or Africa. Hypertension was likely to account for that differential. A follow-up study in each region estimated the relative and attributable risk from hypertension. 3) Heredity/Genetics. The populations in this study shared a common ancestral origin in West Africa. Family studies were undertaken to determine the heritability of blood pressure/hypertension within and between sites. In addition, pilot studies on genetic distance and candidate genes for hypertension were conducted. The study was renewed in FY 1999 to examine in further detail the role of the two most potent hypertensive risk factors, namely dietary sodium and obesity. Randomized studies will be carried out in Nigeria, Jamaica, and Chicago to determine the relative sodium sensitivity of these populations and the factors which condition the blood pressure response. The renin-angiotensin system and renal sodium handling will be compared as causal mechanisms. In addition, body composition will be studied in a large sample of each of the three populations to determine the role of body fat versus lean body mass. Insulin and leptin will be examined and physical activity will be measured by stable isotopes to assess the role of a sedentary lifestyle as a contributor to the hypertension risk experienced by the obese. Existing cohorts will be followed to determine hypertension sequelae and to examine changes in blood pressure with age.

    6. Conditions and Keywords

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

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard Cooper
    Organizational Affiliation
    Loyola University

    12. IPD Sharing Statement

    Citations:
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    7835686
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    Mendez MA, Cooper RS, Luke A, Wilks R, Bennett F, Forrester T. Higher income is more strongly associated with obesity than with obesity-related metabolic disorders in Jamaican adults. Int J Obes Relat Metab Disord. 2004 Apr;28(4):543-50. doi: 10.1038/sj.ijo.0802584.
    Results Reference
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    PubMed Identifier
    14757780
    Citation
    Luke A, Adeyemo A, Kramer H, Forrester T, Cooper RS. Association between blood pressure and resting energy expenditure independent of body size. Hypertension. 2004 Mar;43(3):555-60. doi: 10.1161/01.HYP.0000118020.44335.20. Epub 2004 Feb 2.
    Results Reference
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    PubMed Identifier
    15720304
    Citation
    McKenzie CA, Sinsheimer JS, Adeyemo AA, Cox RD, Southam L, Hugill A, Bouzekri N, Lathrop M, Forrester TE, Cooper RS, Ward R. SNP haplotypes in the angiotensin I-converting enzyme (ACE) gene: analysis of Nigerian family data using gamete competition models. Ann Hum Genet. 2005 Mar;69(Pt 2):227-32. doi: 10.1046/j.1529-8817.2004.00142.x.
    Results Reference
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    PubMed Identifier
    15649942
    Citation
    Zhu X, Fejerman L, Luke A, Adeyemo A, Cooper RS. Haplotypes produced from rare variants in the promoter and coding regions of angiotensinogen contribute to variation in angiotensinogen levels. Hum Mol Genet. 2005 Mar 1;14(5):639-43. doi: 10.1093/hmg/ddi060. Epub 2005 Jan 13.
    Results Reference
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    PubMed Identifier
    9234837
    Citation
    Cooper R, Rotimi C. Hypertension in blacks. Am J Hypertens. 1997 Jul;10(7 Pt 1):804-12. doi: 10.1016/s0895-7061(97)00211-2.
    Results Reference
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    Hypertension in Blacks of West African Origin

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