Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation (NCT03929718) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation
United States50 participantsStarted 2019-04-24
Plain-language summary
The purpose of this study is to accurately determine, using an implantable rhythm monitor, the long-term incidence of new atrial fibrillation after ablation of atrial flutter in those treated with spironolactone compared with standard medical therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* diagnosis of typical AFL confirmed by 12-lead ECG
* no documented AF on ECG, ambulatory monitor, pacemaker or ICD at any time
* scheduled to undergo catheter ablation of the CTI for treatment of AFL
* history of hypertension (HTN) or heart failure (HF) (reduced or preserved systolic function)
Exclusion Criteria:
* history of known AF episodes
* previous CTI or PVI ablation procedure
* other SVT mechanisms demonstrated (AVNRT, AVRT or accessory pathways)
* amiodarone usage within the past 3 months,
* unwillingness to participate or undergo insertable monitor implantation
* hyperkalemia (potassium \> 5.0 mEq/L)
* severe renal disease (Cr \>2.5 mg/dL \[men\], \>2.0 mg/dL \[women, GFR \< 30 mL/min/1.73 m2)
* life expectancy \< 18 months
* prior intolerance to treatment with an aldosterone antagonist
* current treatment with an aldosterone antagonist
* need for treatment with a class I or III AAD for another indication
* operative AFL (occurring within 30 days of surgery) that is expected to resolve
* presence of a cardiac rhythm device (pacemaker or ICD) capable of AF monitoring
* currently pregnant or nursing a child
* unwilling not to become pregnant and to use birth control while taking spironolactone
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Long-Term incidence of new-onset AF after CTI ablation
Timeframe: 24 months
2
Rates of new-onset AF between standard therapy and spironolactone