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

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

Study Overview

• Status: Unknown
• Conditions: 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

• Study Type: Observational
• Enrollment (Anticipated): 2500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Malaysian adult population

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Those who refused consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aldosterone-Renin Ratio	Aldosterone-renin ratio of respondent at the time of sampling	Day 0

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: International Islamic University Malaysia
• Collaborators: University of Malaya; National University of Malaysia; International Medical University; Malaysian Endocrine and Metabolic Society
• Investigators: Principal Investigator: Nor Azmi Kamaruddin, FACE, Malaysian Endocrine and Metabolic Society

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: October 3, 2014
• First Posted (Estimate): October 6, 2014

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Hyperaldosteronism; Primary Aldosteronism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperaldosteronism
• Other Study ID Numbers: MyEndo - PA