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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04327232
• Other study ID #: Monitor-AF
• Status: Recruiting
• Phase: Phase 2
• Start date: May 23, 2018
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2019
• Source: National University Hospital, Singapore
• Contact: Pipin Kojodjojo
• Phone: (+65) 67725286
• Email: pipin_kojodjojo[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Spironolactone 25mg
Mineralocorticoid Receptor Antagonists
• Placebo oral tablet
Placebo

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore
Singapore	National University Hospital	Singapore
Singapore	Ng Teng Fong General Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	University of Otago

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of total time in AF.	Percentage of total time in AF.	18 months
Secondary	Number of AF episodes	Number of AF episodes > 5 minutes duration recorded on pacemaker	18 months
Secondary	Number of symptomatic AF episodes	Number of symptomatic AF episodes	18 months
Secondary	Number of admissions for AF	Number of admissions for AF	18 months
Secondary	Change in LA volumes in millimetre	Change in LA volumes in millimetre assessed by echo scan	18 months
Secondary	Change in LV volumes in millimetre	Change in LV volumes in millimetre assessed by echo scan	18 months
Secondary	Change in systolic and diastolic function	Change in systolic and diastolic function assessed by echo scan	18 months
Secondary	Change in cardiac and systemic markers	Change in cardiac and systemic markers of stretch assessed by biomarkers blood tests - NT-proBNP	18 months
Secondary	Change in cardiac and systemic markers of inflammation	Change in cardiac and systemic markers of inflammation assessed by biomarkers blood tests - hsCRP, myeloperoxidase, ST-2, GD-15, Galectin-3	18 months
Secondary	Change in cardiac and systemic markers of fibrosis	Change in cardiac and systemic markers of fibrosis assessed by biomarkers blood tests - PIIP, type 1 and II procollagen	18 months