Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Piedmont Healthcare
• Treatments: Mineralocorticoid Receptor Antagonists; Spironolactone

Criteria

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