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Aldosterone Antagonist Therapy for Atrial Fibrillation

Q: Can you discuss any prior conducted experiments using Spironolactone?

Currently, Spironolactone has 28 active clinical trials with 7 of those studies in the final phase. Boston is the main centre for these experiments; however, a total of 293 sites are running investigations on this medication.

Q: What clinical conditions is Spironolactone commonly prescribed to address?

Spironolactone is a medication often prescribed to treat primary hyperaldosteronism, but it also has applications for managing <a href="https://www.withpower.com/clinical-trials/cirrhosis">cirrhosis</a> of the liver, certain medical procedures, and <a href="https://www.withpower.com/clinical-trials/acne">acne</a>.

Q: How many participants are affiliated with this research endeavor?

Affirmative. According to clinicaltrials.gov, the trial first appeared on April 24th 2019 and is currently seeking participants with an updated post dated September 29th 2022. This research requires 50 patients from a single medical site to take part.

Q: Is the enrollment process for this trial open at present?

According to the information on clinicaltrials.gov, enrollment for this trial is ongoing. It was first made available on April 24th 2019 and recently edited on September 29th 2022.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial will study whether spironolactone reduces the incidence of new atrial fibrillation after ablation of atrial flutter, as compared to standard medical therapy.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Diabetes related

Infection

Chest pain/discomfort

Breast tenderness/Gynecomastia

Surgical

100%

80%

60%

40%

20%

Study treatment Arm

Spironolactone

Placebo

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

~7340

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Piedmont HealthcareLead Sponsor

22 Previous Clinical Trials

5,827 Total Patients Enrolled

Bruce Stambler, MDPrincipal InvestigatorPiedmont Healthcare

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you discuss any prior conducted experiments using Spironolactone?

"Currently, Spironolactone has 28 active clinical trials with 7 of those studies in the final phase. Boston is the main centre for these experiments; however, a total of 293 sites are running investigations on this medication."

Answered by AI

What clinical conditions is Spironolactone commonly prescribed to address?

"Spironolactone is a medication often prescribed to treat primary hyperaldosteronism, but it also has applications for managing cirrhosis of the liver, certain medical procedures, and acne."

Answered by AI

How many participants are affiliated with this research endeavor?

"Affirmative. According to clinicaltrials.gov, the trial first appeared on April 24th 2019 and is currently seeking participants with an updated post dated September 29th 2022. This research requires 50 patients from a single medical site to take part."

Answered by AI

Is the enrollment process for this trial open at present?

"According to the information on clinicaltrials.gov, enrollment for this trial is ongoing. It was first made available on April 24th 2019 and recently edited on September 29th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation

2019. "Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03929718.