Clinical trial NCT04327232: Mineralocorticoid Antagonism to Stop Progression of Atrial Fibrillation (MONITOR-AF) Study
Official title: Mineralocorticoid Antagonism to Stop Progression of Atrial Fibrillation (MONITOR-AF) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: University of Otago
First posted: 2020-03-31
Enrollment: 184
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 - 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.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Development of persistent AF (defined as the first episode of sustained AF lasting for more than 7 days)
timeFrame: 18 months
Secondary outcomes:
measure: Percentage of total time in AF.
timeFrame: 18 months
measure: Number of AF episodes
timeFrame: 18 months
measure: Number of symptomatic AF episodes
timeFrame: 18 months
measure: Number of admissions for AF
timeFrame: 18 months
measure: Change in LA volumes in millimetre
timeFrame: 18 months
measure: Change in LV volumes in millimetre
timeFrame: 18 months
measure: Change in systolic and diastolic function
timeFrame: 18 months
measure: Change in cardiac and systemic markers
timeFrame: 18 months
measure: Change in cardiac and systemic markers of inflammation
timeFrame: 18 months
measure: Change in cardiac and systemic markers of fibrosis
timeFrame: 18 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: Ng Teng Fong General Hospital
Study officials:
References: