Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-01-01 @ 1:39 AM
Study NCT ID:
NCT04327232
Status:
UNKNOWN
Last Update Posted:
2020-03-31
First Post:
2019-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mineralocorticoid Antagonism to Stop Progression of Atrial Fibrillation (MONITOR-AF) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013148', 'term': 'Spironolactone'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2019-06-12', 'studyFirstSubmitQcDate': '2020-03-30', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of persistent AF (defined as the first episode of sustained AF lasting for more than 7 days)', 'timeFrame': '18 months', 'description': 'Development of persistent AF (defined as the first episode of sustained AF lasting for more than 7 days)'}], 'secondaryOutcomes': [{'measure': 'Percentage of total time in AF.', 'timeFrame': '18 months', 'description': 'Percentage of total time in AF.'}, {'measure': 'Number of AF episodes', 'timeFrame': '18 months', 'description': 'Number of AF episodes \\> 5 minutes duration recorded on pacemaker'}, {'measure': 'Number of symptomatic AF episodes', 'timeFrame': '18 months', 'description': 'Number of symptomatic AF episodes'}, {'measure': 'Number of admissions for AF', 'timeFrame': '18 months', 'description': 'Number of admissions for AF'}, {'measure': 'Change in LA volumes in millimetre', 'timeFrame': '18 months', 'description': 'Change in LA volumes in millimetre assessed by echo scan'}, {'measure': 'Change in LV volumes in millimetre', 'timeFrame': '18 months', 'description': 'Change in LV volumes in millimetre assessed by echo scan'}, {'measure': 'Change in systolic and diastolic function', 'timeFrame': '18 months', 'description': 'Change in systolic and diastolic function assessed by echo scan'}, {'measure': 'Change in cardiac and systemic markers', 'timeFrame': '18 months', 'description': 'Change in cardiac and systemic markers of stretch assessed by biomarkers blood tests - NT-proBNP'}, {'measure': 'Change in cardiac and systemic markers of inflammation', 'timeFrame': '18 months', 'description': 'Change in cardiac and systemic markers of inflammation assessed by biomarkers blood tests - hsCRP, myeloperoxidase, ST-2, GD-15, Galectin-3'}, {'measure': 'Change in cardiac and systemic markers of fibrosis', 'timeFrame': '18 months', 'description': 'Change in cardiac and systemic markers of fibrosis assessed by biomarkers blood tests - PIIP, type 1 and II procollagen'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This proposal details the implementation of an international (Singapore and New Zealand) multi-centre study to test a novel therapeutic strategy aimed at reducing the burden of atrial fibrillation - an important medical condition with major healthcare implications. Unique aspects of this study include i) a non-arrhythmic treatment target (mineralocorticoid receptor antagonism) -targeting the arrhythmogenic substrate of AF before it becomes permanently established, ii) the use of pacemaker monitoring capability to accurately document AF burden, thus increasing the power of the study and iii) multi-national collaborative, double blind design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 21 years (without child-bearing potential for women);\n* With a permanent pacemaker capable of AF monitoring;\n* Device documented AF in the last 12 months; Defined as:\n\n i. atrial high rate events (AHRE) \\> 220 bpm for \\>1% of the time; or ii. \\> 6 mins on at least one occasion\n\nExclusion Criteria:\n\n* Persistent (defined as sustained AF lasting continuously for 7 or more days)\n* History of heart failure with indication for MRAs\n* Any existing clinical indication for MRA or K+ sparing diuretic such as uncontrolled hypertension or oedema\n* Contraindication to MRA\n* Severe renal dysfunction (eGFR \\<30ml/min by CKD-Epi)\n* Sustained hyperkalaemia (defined as K+ \\>5mmol/L in the absence of reversible cause)\n* Receiving AF suppression pacing\n* Women of child bearing potential\n* Patients taking medications which may interact with the study drug or increase the level of potassium in the blood, include lithium, amiloride, cyclosporine, eplerenone, tacrolimus, and triamterene.'}, 'identificationModule': {'nctId': 'NCT04327232', 'briefTitle': 'Mineralocorticoid Antagonism to Stop Progression of Atrial Fibrillation (MONITOR-AF) Study', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Mineralocorticoid Antagonism to Stop Progression of Atrial Fibrillation (MONITOR-AF) Study', 'orgStudyIdInfo': {'id': 'Monitor-AF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': "For patients randomized to active experimental arm: Spironolactone\n\nPatient will receive study drug for 18 months. Study drug dosages are 1 tablet alternate day, 1 tablet per day, or 2 tablets per day, with 1 tablet being 25mg spironolactone. Study drugs are titrated every 3 months based on patients' potassium and eGFR blood tests results.", 'interventionNames': ['Drug: Spironolactone 25mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': "For patients randomized to control arm: Placebo\n\nPatient will receive placebo for 18 months. Placebo dosages are 1 tablet alternate day, 1 tablet per day, or 2 tablets per day. Placebo are titrated every 3 months based on patients' potassium and eGFR blood tests results.", 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Spironolactone 25mg', 'type': 'DRUG', 'description': 'Mineralocorticoid Receptor Antagonists', 'armGroupLabels': ['Active']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Pipin Kojodjojo', 'role': 'CONTACT', 'email': 'pipin_kojodjojo@nuhs.edu.sg'}], 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '308433', 'city': 'Singapore', 'status': 'NOT_YET_RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Wee Kian Kenny Tan', 'role': 'CONTACT', 'email': 'Kenny_WK_TAN@ttsh.com.sg'}], 'facility': 'Tan Tock Seng Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '529889', 'city': 'Singapore', 'status': 'NOT_YET_RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Vern Hsen Tan', 'role': 'CONTACT', 'email': 'tan.vern.hsen@singhealth.com.sg'}], 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '609606', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Pipin Kojodjojo', 'role': 'CONTACT', 'email': 'pipin_kojodjojo@nuhs.edu.sg'}], 'facility': 'Ng Teng Fong General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Pipin Kojodjojo', 'role': 'CONTACT', 'email': 'pipin_kojodjojo@nuhs.edu.sg', 'phone': '(+65) 67725286'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Otago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}