Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT04327232
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
100 Years
Study:
NCT04327232
Study Brief:
Protocol Section:
NCT04327232