Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study

Primary Aldosteronism Clinical Trial

— MyEndo-PA  

Official title:

Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02257450
• Other study ID #: MyEndo - PA
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 2, 2014
• Last updated: October 17, 2016
• Start date: October 2014
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: International Islamic University Malaysia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: National Medical Research Register
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2500
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old and above

• Malaysian citizen

• Consent given

Exclusion Criteria:

• Those who refused consent

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
International Islamic University Malaysia	International Medical University, Malaysian Endocrine and Metabolic Society, National University of Malaysia, University of Malaya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aldosterone-Renin Ratio	Aldosterone-renin ratio of respondent at the time of sampling	Day 0	No
Secondary	Level of Inflammatory Markers	Level of inflammatory markers (IL-6, hs-CRP) among respondents at the time of sampling	Day 0	No
Secondary	Level of cardiovascular markers	Level of cardiovascular markers (BNP, PAI-1) among respondents at the time of sampling	Day 0	No