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

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ClinicalTrials.gov Identifier: NCT02257450
Recruitment Status : Unknown
Verified October 2016 by Dr Mohamnmad Arif Shahar, International Islamic University Malaysia.
Recruitment status was:  Enrolling by invitation
First Posted : October 6, 2014
Last Update Posted : October 18, 2016
Sponsor:
Collaborators:
Malaysian Endocrine and Metabolic Society
National University of Malaysia
University of Malaya
International Medical University
Information provided by (Responsible Party):
Dr Mohamnmad Arif Shahar, International Islamic University Malaysia

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

Condition or disease
Primary Aldosteronism

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

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Study Type : Observational
Estimated 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 : October 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Aldosterone-Renin Ratio [ Time Frame: Day 0 ]
    Aldosterone-renin ratio of respondent at the time of sampling


Secondary Outcome Measures :
  1. Level of Inflammatory Markers [ Time Frame: Day 0 ]
    Level of inflammatory markers (IL-6, hs-CRP) among respondents at the time of sampling

  2. Level of cardiovascular markers [ Time Frame: Day 0 ]
    Level of cardiovascular markers (BNP, PAI-1) among respondents at the time of sampling


Biospecimen Retention:   Samples Without DNA
Serum, plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Malaysian adult population
Criteria

Inclusion Criteria:

  • 18 years old and above
  • Malaysian citizen
  • Consent given

Exclusion Criteria:

  • Those who refused consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02257450


Sponsors and Collaborators
International Islamic University Malaysia
Malaysian Endocrine and Metabolic Society
National University of Malaysia
University of Malaya
International Medical University
Investigators
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Principal Investigator: Nor Azmi Kamaruddin, FACE Malaysian Endocrine and Metabolic Society
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Responsible Party: Dr Mohamnmad Arif Shahar, Assist Prof, International Islamic University Malaysia
ClinicalTrials.gov Identifier: NCT02257450    
Other Study ID Numbers: MyEndo - PA
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Keywords provided by Dr Mohamnmad Arif Shahar, International Islamic University Malaysia:
Primary Aldosteronism
Hyperaldosteronism
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases