What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation include antiarrhythmic drugs, rate control medications, and anticoagulants. Antiarrhythmic drugs can cause proarrhythmic effects, dizziness, and gastrointestinal issues. Rate control medications, such as beta-blockers and calcium channel blockers, may lead to bradycardia, hypotension, and fatigue. Anticoagulants carry a risk of bleeding. Spironolactone, an aldosterone antagonist, can cause hyperkalemia, gynecomastia, and menstrual irregularities. Monitoring and managing these side effects are crucial for patient safety.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Atrial Fibrillation (AF). Spironolactone, an aldosterone antagonist, has been studied for its effects on AF, particularly in patients with heart failure, but it is not primarily approved for AF treatment. Other FDA-approved antiarrhythmic drugs for AF include amiodarone, dronedarone, and sotalol. Dronedarone, for instance, has been used to reduce cardiovascular events in patients with paroxysmal or persistent AF, although it is not recommended for permanent AF due to increased risks. Additionally, angiotensin receptor blockers (ARBs) and angiotensin-converting enzyme (ACE) inhibitors have been used to maintain sinus rhythm in AF patients, particularly those with underlying heart conditions.

What other types of research exist?

Promising novel alternatives to spironolactone for atrial fibrillation patients include the use of novel oral anticoagulants (NOACs) such as apixaban and rivaroxaban, which have shown efficacy in stroke prevention and AF management. Additionally, the use of antiarrhythmic drugs like dronedarone and vernakalant for rhythm control, as well as the potential role of implantable cardiac devices, are emerging as effective strategies. These alternatives offer improved safety profiles and efficacy in maintaining sinus rhythm and preventing AF-related complications.

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Aldosterone Antagonist Therapy for Atrial Fibrillation

Q: What is the mechanism of action of this treatment?

Atrial Fibrillation (AF) treatments primarily aim to control heart rate, maintain sinus rhythm, and prevent thromboembolism. Spironolactone, an aldosterone antagonist, helps by reducing fibrosis and inflammation in the heart, potentially lowering the incidence of AF. Rate control medications, such as beta-blockers and calcium channel blockers, slow down the heart rate by inhibiting the AV node, making AF symptoms more manageable. Rhythm control strategies, including antiarrhythmic drugs and cardioversion, aim to restore and maintain normal heart rhythm. These treatments are crucial for AF patients as they help manage symptoms, reduce the risk of stroke, and improve overall heart function.

Phase < 1

Waitlist Available

Led By Bruce Stambler, MD

Research Sponsored by Piedmont Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of hypertension (HTN) or heart failure (HF) (reduced or preserved systolic function)

Scheduled to undergo catheter ablation of the CTI for treatment of AFL

Must not have

Severe renal disease (Cr >2.5 mg/dL [men], >2.0 mg/dL [women, GFR < 30 mL/min/1.73 m2)

Previous CTI or PVI ablation procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Spironolactone may cause side effects like high potassium levels (hyperkalemia), kidney problems, hormonal changes (like breast enlargement in men), digestive issues, dizziness, and rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a history of high blood pressure or heart failure.

Select...

I am scheduled for a procedure to treat my heart rhythm problem.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is severely impaired.

Select...

I have had a CTI or PVI ablation procedure before.

Select...

I have had episodes of atrial fibrillation.

Select...

I am currently taking medication that blocks aldosterone.

Select...

I agree to use birth control while taking spironolactone and not to become pregnant.

Select...

I am not willing to have a device implanted for monitoring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Long-Term incidence of new-onset AF after CTI ablation

Rates of new-onset AF between standard therapy and spironolactone

Side effects data

From 2022 Phase 4 trial • 79 Patients • NCT02169089

Hypotension

Hyperkalemia

Infection

Diabetes related

Surgical

Chest pain/discomfort

Breast tenderness/Gynecomastia

100%

80%

60%

40%

20%

Study treatment Arm

Spironolactone

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spironolactone

2005

Completed Phase 4

~14580

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Atrial Fibrillation (AF) treatments primarily aim to control heart rate, maintain sinus rhythm, and prevent thromboembolism. Spironolactone, an aldosterone antagonist, helps by reducing fibrosis and inflammation in the heart, potentially lowering the incidence of AF. Rate control medications, such as beta-blockers and calcium channel blockers, slow down the heart rate by inhibiting the AV node, making AF symptoms more manageable. Rhythm control strategies, including antiarrhythmic drugs and cardioversion, aim to restore and maintain normal heart rhythm. These treatments are crucial for AF patients as they help manage symptoms, reduce the risk of stroke, and improve overall heart function.