Primary AldosteronismMyEndo-PANCT02257450
Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study
An observational study of Primary Aldosteronism, run by International Islamic University Malaysia.
Trial summary
This research focuses on the prevalence of Primary Aldosteronism in the Malaysian adult population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Aldosteronism
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Malaysian adult population
Who may be able to join
- 18 years old and above
- Malaysian citizen
- Consent given
Who cannot join
- Those who refused consent
About this study
This research focuses on the prevalence of Primary Aldosteronism in the Malaysian adult population.
Read the 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
- Conditions
- Primary Aldosteronism
- Keywords
- Primary Aldosteronism, Hyperaldosteronism
- Medical subject headings
- Hyperaldosteronism
What is being measured
The primary outcome is the main question the study is designed to answer.
Aldosterone-Renin Ratio
Aldosterone-renin ratio of respondent at the time of sampling
Measured: Day 0
Secondary outcomes (2)
Level of Inflammatory Markers
Level of inflammatory markers (IL-6, hs-CRP) among respondents at the time of sampling
Measured: Day 0
Level of cardiovascular markers
Level of cardiovascular markers (BNP, PAI-1) among respondents at the time of sampling
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Islamic University Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysian Endocrine and Metabolic Society, National University of Malaysia, University of Malaya, IMU University, Malaysia
- Responsible party
- Principal investigator, Dr Mohamnmad Arif Shahar, International Islamic University Malaysia
- Investigators
- Nor Azmi Kamaruddin, FACE, Principal investigator, Malaysian Endocrine and Metabolic Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257450
- Sponsor's protocol ID
- MyEndo - PA
- Acronym
- MyEndo-PA
- Status last verified
- Oct 2016
- First submitted
- 2 Oct 2014
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study
- ClinicalTrials.gov ID
- NCT02257450
- Acronym / sponsor ID
- MyEndo-PA / MyEndo - PA
- Conditions
- Primary Aldosteronism
- Keywords
- Primary Aldosteronism, Hyperaldosteronism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- International Islamic University MalaysiaUniversity, hospital or other
- Collaborators
- Malaysian Endocrine and Metabolic Society, National University of Malaysia, University of Malaya, IMU University, Malaysia
- Study start
- Oct 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Malaysian adult population
Key inclusion criteria (3 listed)
- 18 years old and above
- Malaysian citizen
- Consent given
Key exclusion criteria (1 listed)
- Those who refused consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aldosterone-Renin Ratio
Time frame: Day 0
Aldosterone-renin ratio of respondent at the time of sampling
2 secondary outcomes
Level of Inflammatory Markers
Time frame: Day 0
Level of cardiovascular markers
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
Related trials for Primary Aldosteronism
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Not yet recruitingPhase 2
A Phase Ⅱ Clinical Trial of SYH2072 Tablets in Participants With Primary Aldosteronism
Primary Aldosteronism
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Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
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Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruiting
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
Primary Aldosteronism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nor Azmi Kamaruddin, FACE principal investigator
Malaysian Endocrine and Metabolic Society
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism, run by International Islamic University Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aldosterone-Renin Ratio (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.