An Early Phase 1 interventional study of Spironolactone and No Spironolactone in AFib, sponsored by Piedmont Healthcare. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Piedmont Healthcare · Early Phase 1, Interventional, and Treatment
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.
Catheter ablation of the cavotricuspid isthmus (CTI) is an effective and safe procedure in patients with atrial flutter (AFL) with excellent long-term results in preventing AFL recurrences. However, new-onset atrial fibrillation (AF) commonly develops after this procedure and has important clinical implications for patient management. Few studies have assessed the long-term incidence and prevalence of AF after CTI ablation via intensive continuous rhythm monitoring with an implantable cardiac monitor. Furthermore, whether the development of AF can be impacted beneficially by adjunctive therapeutic approaches is not known. The co-primary objectives of this pilot study in patients with typical atrial flutter (AFL) but no previously detected AF are: 1) to accurately determine the long-term incidence of new-onset AF after CTI ablation using an implantable rhythm monitor; 2) to compare the rates of new onset AF in subjects randomized to standard, usual-care, medical therapy following CTI ablation compared with those randomized to treatment with an aldosterone antagonist (spironolactone) in addition to their usual care medications. The patient population will be subjects with typical atrial flutter and a history of hypertension or heart failure, but no known AF episodes, scheduled to undergo catheter ablation of the CTI for treatment of AFL. Patients will be randomized to remain on their standard, usual-care. medications or to take oral spironolactone (a standard, FDA-approved medication used in the treatment of hypertension and heart failure) starting after their ablation procedure. The primary study endpoint will be any atrial tachyarrhythmia episode (AF, AFL or atrial tachycardia) lasting greater than one minute detected via the implanted cardiac monitor after CTI ablation during long-term follow-up. The incidence of new-onset AF after CTI ablation will be compared between subjects randomized to be treated with usual care vs. those treated with usual care plus spironolactone on an intention to treat basis.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 50 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Piedmont Healthcare is the lead sponsor of 17 studies on the registry; none are open to participants now.
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Exclusion Criteria:
subjects undergoing CTI ablation
Drug: No Spironolactone
subjects treated with an aldosterone antagonist after CTI ablation
Drug: Spironolactone
receive spironolactone treatment after CTI ablation
no spironolactone treatment
Long-Term incidence of new-onset AF after CTI ablation
1. To accurately determine the long-term incidence of new-onset AF after CTI ablation using an implantable rhythm monitor
Time frame: 24 months
Rates of new-onset AF between standard therapy and spironolactone
2. To compare the rates of new onset AF in subjects randomized to standard medical therapy following CTI ablation compared with those randomized to treatment with an aldosterone antagonist (spironolactone)
Time frame: 24 months
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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