Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study

• Conditions: Primary Aldosteronism

• Registration Number: NCT02257450
• Lead Sponsor: International Islamic University Malaysia

Brief Summary

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

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-03
• Study First Posted: 2014-10-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

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

Exclusion Criteria

• Those who refused consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aldosterone-Renin Ratio	Day 0	Aldosterone-renin ratio of respondent at the time of sampling

Secondary Outcome Measures

Name	Time	Method
Level of Inflammatory Markers	Day 0	Level of inflammatory markers (IL-6, hs-CRP) among respondents at the time of sampling
Level of cardiovascular markers	Day 0	Level of cardiovascular markers (BNP, PAI-1) among respondents at the time of sampling