Atrial FibrillationPhase 2NCT04327232
Mineralocorticoid Antagonism to Stop Progression of Atrial Fibrillation (MONITOR-AF) Study
A Phase 2 study testing Spironolactone 25mg in people with Atrial Fibrillation, run by National University Hospital, Singapore at 4 sites in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Spironolactone 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 4 sitesSingapore
- Study dates
- 23 May 2018to 31 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- atrial high rate events (AHRE) > 220 bpm for >1% of the time; or ii. > 6 mins on at least one occasion
Who cannot join
- 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)
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- 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 locations and contacts
4 sites in 1 country.
Singapore4 sites, 4 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Pipin Kojodjojo, pipin_kojodjojo@nuhs.edu.sg
- Not yet recruiting
Tan Tock Seng Hospital
Singapore, 308433
Wee Kian Kenny Tan, Kenny_WK_TAN@ttsh.com.sg
- Not yet recruiting
Changi General Hospital
Singapore, 529889
Vern Hsen Tan, tan.vern.hsen@singhealth.com.sg
- Recruiting
Ng Teng Fong General Hospital
Singapore, 609606
Pipin Kojodjojo, pipin_kojodjojo@nuhs.edu.sg
About this study
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Spironolactone 25mg, Placebo oral tablet
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone 25mgDrug
Mineralocorticoid Receptor Antagonists
Placebo oral tabletDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 18 months
Secondary outcomes (10)
Percentage of total time in AF.
Percentage of total time in AF.
Measured: 18 months
Number of AF episodes
Number of AF episodes > 5 minutes duration recorded on pacemaker
Measured: 18 months
Number of symptomatic AF episodes
Number of symptomatic AF episodes
Measured: 18 months
Number of admissions for AF
Number of admissions for AF
Measured: 18 months
Change in LA volumes in millimetre
Change in LA volumes in millimetre assessed by echo scan
Measured: 18 months
Change in LV volumes in millimetre
Change in LV volumes in millimetre assessed by echo scan
Measured: 18 months
Change in systolic and diastolic function
Change in systolic and diastolic function assessed by echo scan
Measured: 18 months
Change in cardiac and systemic markers
Change in cardiac and systemic markers of stretch assessed by biomarkers blood tests - NT-proBNP
Measured: 18 months
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
Measured: 18 months
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start23 May 2018
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- University of Otago
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327232
- Sponsor's protocol ID
- Monitor-AF
- Status last verified
- Jun 2019
- First submitted
- 12 Jun 2019
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mineralocorticoid Antagonism to Stop Progression of Atrial Fibrillation (MONITOR-AF) Study
- ClinicalTrials.gov ID
- NCT04327232
- Acronym / sponsor ID
- Monitor-AF
- Conditions
- Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- University of Otago
- Study start
- 23 May 2018 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Spironolactone 25mgFor 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. |
| Control | Placebo comparator | Drug: Placebo oral tabletFor 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. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spironolactone 25mgMineralocorticoid Receptor Antagonists | Drug | Active |
| Placebo oral tabletPlacebo | Drug | Control |
Primary outcome
Development of persistent AF (defined as the first episode of sustained AF lasting for more than 7 days)
Time frame: 18 months
Development of persistent AF (defined as the first episode of sustained AF lasting for more than 7 days)
10 secondary outcomes
Percentage of total time in AF.
Time frame: 18 months
Number of AF episodes
Time frame: 18 months
Number of symptomatic AF episodes
Time frame: 18 months
Number of admissions for AF
Time frame: 18 months
Change in LA volumes in millimetre
Time frame: 18 months
Change in LV volumes in millimetre
Time frame: 18 months
Change in systolic and diastolic function
Time frame: 18 months
Change in cardiac and systemic markers
Time frame: 18 months
Change in cardiac and systemic markers of inflammation
Time frame: 18 months
Change in cardiac and systemic markers of fibrosis
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spironolactone 25mg in people with Atrial Fibrillation, run by National University Hospital, Singapore at 4 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pipin Kojodjojo ((+65) 67725286, pipin_kojodjojo@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of persistent AF (defined as the first episode of sustained AF lasting for more than 7 days) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.