Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-02-17 @ 10:31 PM
Study NCT ID:
NCT02257450
Status:
UNKNOWN
Last Update Posted:
2016-10-18
First Post:
2014-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006929', 'term': 'Hyperaldosteronism'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2014-10-02', 'studyFirstSubmitQcDate': '2014-10-03', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aldosterone-Renin Ratio', 'timeFrame': 'Day 0', 'description': 'Aldosterone-renin ratio of respondent at the time of sampling'}], 'secondaryOutcomes': [{'measure': 'Level of Inflammatory Markers', 'timeFrame': 'Day 0', 'description': 'Level of inflammatory markers (IL-6, hs-CRP) among respondents at the time of sampling'}, {'measure': 'Level of cardiovascular markers', 'timeFrame': 'Day 0', 'description': 'Level of cardiovascular markers (BNP, PAI-1) among respondents at the time of sampling'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Primary Aldosteronism', 'Hyperaldosteronism'], 'conditions': ['Primary Aldosteronism']}, 'descriptionModule': {'briefSummary': 'This research focuses on the prevalence of Primary Aldosteronism in the Malaysian adult population.', 'detailedDescription': '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.\n\nThis 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.\n\nDiagnosis 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Malaysian adult population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old and above\n* Malaysian citizen\n* Consent given\n\nExclusion Criteria:\n\n* Those who refused consent'}, 'identificationModule': {'nctId': 'NCT02257450', 'acronym': 'MyEndo-PA', 'briefTitle': 'Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study', 'organization': {'class': 'OTHER', 'fullName': 'International Islamic University Malaysia'}, 'officialTitle': 'Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study', 'orgStudyIdInfo': {'id': 'MyEndo - PA'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nor Azmi Kamaruddin, FACE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Malaysian Endocrine and Metabolic Society'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Islamic University Malaysia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Malaysian Endocrine and Metabolic Society', 'class': 'OTHER'}, {'name': 'National University of Malaysia', 'class': 'OTHER'}, {'name': 'University of Malaya', 'class': 'OTHER'}, {'name': 'IMU University, Malaysia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist Prof', 'investigatorFullName': 'Dr Mohamnmad Arif Shahar', 'investigatorAffiliation': 'International Islamic University Malaysia'}}}}