Mineralocorticoid Antagonism to Stop Progression of Atrial Fibrillation (MONITOR-AF) Study

National University Health System (NUHS)

Status and phase: Unknown; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: Placebo oral tablet; Drug: Spironolactone 25mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04327232

Monitor-AF

Details and patient eligibility

About

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.

Enrollment: 184 estimated patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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184 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

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.

Treatment:

Drug: Spironolactone 25mg

Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo oral tablet