Clinical trial NCT02257450: Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study
Official title: Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Aldosteronism
Keywords: Primary Aldosteronism
Hyperaldosteronism
Lead sponsor: International Islamic University Malaysia
Sponsor class: OTHER
Collaborators: name: Malaysian Endocrine and Metabolic Society
name: National University of Malaysia
name: University of Malaya
name: International Medical University
First posted: 2014-10-06
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Malaysian adult population

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Those who refused consent

Primary outcomes:
measure: Aldosterone-Renin Ratio
timeFrame: Day 0
Secondary outcomes:
measure: Level of Inflammatory Markers
timeFrame: Day 0
measure: Level of cardiovascular markers
timeFrame: Day 0
Other outcomes:
Locations:
Study officials:
affiliation: Malaysian Endocrine and Metabolic Society
name: Nor Azmi Kamaruddin, FACE
role: PRINCIPAL_INVESTIGATOR
References: