Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation

NCT03929718 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: AVOID-AF
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AFib

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  24 months

Study Arms (2)

Standard Therapy

ACTIVE COMPARATOR

subjects undergoing CTI ablation

Drug: No Spironolactone

Interventional Therapy

EXPERIMENTAL

subjects treated with an aldosterone antagonist after CTI ablation

Drug: Spironolactone

Interventions

Spironolactone DRUG

receive spironolactone treatment after CTI ablation

Interventional Therapy

No Spironolactone DRUG

no spironolactone treatment

Standard Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Piedmont Healthcare: lead

Study Sites (1)

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Interventions

Spironolactone

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bruce Stambler, MD

  Piedmont Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, pilot study

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: April 24, 2019
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

US (1)