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| Name | Class |
|---|---|
| University of Otago | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | For patients randomized to active experimental arm: Spironolactone Patient 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. |
|
| Control | Placebo Comparator | For patients randomized to control arm: Placebo Patient 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone 25mg | Drug | Mineralocorticoid Receptor Antagonists |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Development of persistent AF (defined as the first episode of sustained AF lasting for more than 7 days) | Development of persistent AF (defined as the first episode of sustained AF lasting for more than 7 days) | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of total time in AF. | Percentage of total time in AF. | 18 months |
| Number of AF episodes | Number of AF episodes > 5 minutes duration recorded on pacemaker |
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Inclusion Criteria:
Age > 21 years (without child-bearing potential for women);
With a permanent pacemaker capable of AF monitoring;
Device documented AF in the last 12 months; Defined as:
i. atrial high rate events (AHRE) > 220 bpm for >1% of the time; or ii. > 6 mins on at least one occasion
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pipin Kojodjojo | Contact | (+65) 67725286 | pipin_kojodjojo@nuhs.edu.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Recruiting | Singapore | 119074 | Singapore |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Placebo oral tablet |
| Drug |
Placebo |
|
| 18 months |
| Number of symptomatic AF episodes | Number of symptomatic AF episodes | 18 months |
| Number of admissions for AF | Number of admissions for AF | 18 months |
| Change in LA volumes in millimetre | Change in LA volumes in millimetre assessed by echo scan | 18 months |
| Change in LV volumes in millimetre | Change in LV volumes in millimetre assessed by echo scan | 18 months |
| Change in systolic and diastolic function | Change in systolic and diastolic function assessed by echo scan | 18 months |
| Change in cardiac and systemic markers | Change in cardiac and systemic markers of stretch assessed by biomarkers blood tests - NT-proBNP | 18 months |
| Change in cardiac and systemic markers of inflammation | Change in cardiac and systemic markers of inflammation assessed by biomarkers blood tests - hsCRP, myeloperoxidase, ST-2, GD-15, Galectin-3 | 18 months |
| Change in cardiac and systemic markers of fibrosis | Change in cardiac and systemic markers of fibrosis assessed by biomarkers blood tests - PIIP, type 1 and II procollagen | 18 months |
| Tan Tock Seng Hospital | Not yet recruiting | Singapore | 308433 | Singapore |
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| Changi General Hospital | Not yet recruiting | Singapore | 529889 | Singapore |
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| Ng Teng Fong General Hospital | Recruiting | Singapore | 609606 | Singapore |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |