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 range18 Years
SexALL
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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
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