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

NCT ID: NCT04327232

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-23

Study Completion Date

2022-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Active

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.

Group Type EXPERIMENTAL

Spironolactone 25mg

Intervention Type DRUG

Mineralocorticoid Receptor Antagonists

Control

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.

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Placebo

Interventions

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Spironolactone 25mg

Mineralocorticoid Receptor Antagonists

Intervention Type DRUG

Placebo oral tablet

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Otago

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National University Hospital

Singapore, , Singapore

Site Status RECRUITING

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status NOT_YET_RECRUITING

Changi General Hospital

Singapore, , Singapore

Site Status NOT_YET_RECRUITING

Ng Teng Fong General Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Pipin Kojodjojo

Role: CONTACT

Phone: (+65) 67725286

Email: [email protected]

Facility Contacts

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Pipin Kojodjojo

Role: primary

Wee Kian Kenny Tan

Role: primary

Vern Hsen Tan

Role: primary

Pipin Kojodjojo

Role: primary

Other Identifiers

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Monitor-AF

Identifier Type: -

Identifier Source: org_study_id