MyEndo-PA: Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study

Sponsor
International Islamic University Malaysia (Other)
Overall Status
Unknown status
CT.gov ID
NCT02257450
Collaborator
Malaysian Endocrine and Metabolic Society (Other), National University of Malaysia (Other), University of Malaya (Other), International Medical University (Other)
2,500
32

Study Details

Study Description

Brief Summary

This research focuses on the prevalence of Primary Aldosteronism in the Malaysian adult population.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hypertension (HPT) is a very common disease, expensive to treat with serious morbidity and mortality. In Malaysia, from the NHMS III conducted in 2006, HPT affects more than 36% of adults. Essential HPT (HPT with no identifiable cause) accounts for approximately 85% of cases, whereas 15% have identifiable conditions (secondary cause). The detection of a secondary cause of HPT is important as the condition is reversible when detected early. Primary aldosteronism (PA) has been identified as the commonest cause of secondary HPT. At present, PA has been regarded as the commonest and potentially curable, with a prevalence of 5-13% [1-7]. If this condition is detected early, the chances of cure from hypertension have been reported up to 80% of cases.

    This will translate to a major impact to the Malaysian health-care budget. The costs spent on life-long BP medications and complications related to HPT can be reduced enormously. PA is a type of hormonal disorder that leads to high blood pressure (BP). In PA, the adrenal glands produce too much aldosterone causing sodium retention and potassium excretion. The excess sodium then increased the blood volume and BP.

    Diagnosis and treatment of this condition are of paramount importance because people with this form of high BP have a higher risk of heart attack, stroke, kidney impairment, metabolic abnormality and reduce quality of life compared to patients with high BP not due to this condition. More importantly, the high BP associated with PA may be curable. This research will be conducted as a multicenter nation-wide study in Malaysia. The research aimed to study the prevalence of this disease in the investigators Malaysian population, determine the underlying mechanisms why this disease is associated with higher complication rate through cardiovascular and inflammatory markers, and identify the genes causing this disease, hence provide a more rapid diagnostic test and possibility of curing the disease with genetic therapy

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2500 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study
    Study Start Date :
    Oct 1, 2014
    Anticipated Primary Completion Date :
    Jun 1, 2017
    Anticipated Study Completion Date :
    Jun 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Aldosterone-Renin Ratio [Day 0]

      Aldosterone-renin ratio of respondent at the time of sampling

    Secondary Outcome Measures

    1. Level of Inflammatory Markers [Day 0]

      Level of inflammatory markers (IL-6, hs-CRP) among respondents at the time of sampling

    2. Level of cardiovascular markers [Day 0]

      Level of cardiovascular markers (BNP, PAI-1) among respondents at the time of sampling

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 18 years old and above

    • Malaysian citizen

    • Consent given

    Exclusion Criteria:
    • Those who refused consent

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • International Islamic University Malaysia
    • Malaysian Endocrine and Metabolic Society
    • National University of Malaysia
    • University of Malaya
    • International Medical University

    Investigators

    • Principal Investigator: Nor Azmi Kamaruddin, FACE, Malaysian Endocrine and Metabolic Society

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Mohamnmad Arif Shahar, Assist Prof, International Islamic University Malaysia
    ClinicalTrials.gov Identifier:
    NCT02257450
    Other Study ID Numbers:
    • MyEndo - PA
    First Posted:
    Oct 6, 2014
    Last Update Posted:
    Oct 18, 2016
    Last Verified:
    Oct 1, 2016
    Keywords provided by Dr Mohamnmad Arif Shahar, Assist Prof, International Islamic University Malaysia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 18, 2016