Status:
UNKNOWN
Mineralocorticoid Antagonism to Stop Progression of Atrial Fibrillation (MONITOR-AF) Study
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
University of Otago
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
21-100 years
Phase:
PHASE2
Brief Summary
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 - a...
Eligibility Criteria
Inclusion
- 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
- Persistent (defined as sustained AF lasting continuously for 7 or more days)
- History of heart failure with indication for MRAs
- Any existing clinical indication for MRA or K+ sparing diuretic such as uncontrolled hypertension or oedema
- Contraindication to MRA
- Severe renal dysfunction (eGFR \<30ml/min by CKD-Epi)
- Sustained hyperkalaemia (defined as K+ \>5mmol/L in the absence of reversible cause)
- Receiving AF suppression pacing
- Women of child bearing potential
- 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.
Key Trial Info
Start Date :
May 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2022
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04327232
Start Date
May 23 2018
End Date
May 31 2022
Last Update
March 31 2020
Active Locations (4)
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1
National University Hospital
Singapore, Singapore, 119074
2
Tan Tock Seng Hospital
Singapore, Singapore, 308433
3
Changi General Hospital
Singapore, Singapore, 529889
4
Ng Teng Fong General Hospital
Singapore, Singapore, 609606