Trial Summary
What is the purpose of this trial?This trial is testing if adding spironolactone to usual care can prevent new heart rhythm problems in patients with atrial flutter who have high blood pressure or heart failure. Spironolactone has been shown to reduce arrhythmias and maintain magnesium balance in patients with congestive heart failure.
Eligibility Criteria
This trial is for adults with a history of hypertension or heart failure, who have had atrial flutter confirmed by ECG and are scheduled for catheter ablation. They must not have any record of atrial fibrillation, severe kidney issues, hyperkalemia, or be on certain heart medications. Pregnant women and those unwilling to use birth control while taking spironolactone cannot participate.Inclusion Criteria
You have been diagnosed with typical atrial flutter confirmed by a 12-lead ECG.
You do not have a documented irregular heart rhythm on any heart monitoring tests.
I have a history of high blood pressure or heart failure.
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Exclusion Criteria
Your blood potassium level is too high.
I need a specific heart medication for another health issue.
My kidney function is severely impaired.
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Participant Groups
The study aims to see if the drug spironolactone can prevent new cases of atrial fibrillation after treating atrial flutter with ablation. Participants will either receive spironolactone or standard medical therapy without it, monitored long-term via an implantable rhythm device.
2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional TherapyExperimental Treatment1 Intervention
subjects treated with an aldosterone antagonist after CTI ablation
Group II: Standard TherapyActive Control1 Intervention
subjects undergoing CTI ablation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Piedmont Heart InstituteAtlanta, GA
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Who Is Running the Clinical Trial?
Piedmont HealthcareLead Sponsor