NCT04327232

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P50-P75 for phase_2 atrial-fibrillation

Timeline
Completed

Started May 2018

Longer than P75 for phase_2 atrial-fibrillation

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2019

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

March 31, 2020

Status Verified

June 1, 2019

Enrollment Period

4 years

First QC Date

June 12, 2019

Last Update Submit

March 30, 2020

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (10)

  • Percentage of total time in AF.

    18 months

  • Number of AF episodes

    18 months

  • Number of symptomatic AF episodes

    18 months

  • Number of admissions for AF

    18 months

  • Change in LA volumes in millimetre

    18 months

  • +5 more secondary outcomes

Study Arms (2)

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.

Drug: Spironolactone 25mg

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.

Drug: Placebo oral tablet

Interventions

Spironolactone 25mgDRUG

Mineralocorticoid Receptor Antagonists

Active
Placebo oral tabletDRUG

Placebo

Control

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Tan Tock Seng Hospital

Singapore, 308433, Singapore

NOT YET RECRUITING

Changi General Hospital

Singapore, 529889, Singapore

NOT YET RECRUITING

Ng Teng Fong General Hospital

Singapore, 609606, Singapore

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Pipin Kojodjojo

CONTACT

(+65) 67725286pipin_kojodjojo@nuhs.edu.sg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2019

First Posted

March 31, 2020

Study Start

May 23, 2018

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

March 31, 2020

Record last verified: 2019-06

Locations

SG(4)