NCT03929718Active, not recruitingEarly phase 1
Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation
A Randomized Prospective Pilot Study to Evaluate Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation (AF) in Patients With Atrial Flutter (AFL), But no Previously Detected AF, Undergoing caVOtricuspID Isthmus Ablation
Source: ClinicalTrials.gov · Last updated 29 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 24 Apr 2019
- Start date
- 24 Apr 2019
- Primary completion date
- Sept 2025
- Lead sponsor
- Piedmont Healthcare
- Diseases
- Atrial fibrillation
- NCT number
- NCT03929718
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 50
- From 24 Apr 2019 to the primary completion date, Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous CTI or PVI ablation procedure
- 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
Other illness
- history of known AF episodes
- presence of a cardiac rhythm device (pacemaker or ICD) capable of AF monitoring
Lab values
- 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)
Other
- other SVT mechanisms demonstrated (AVNRT, AVRT or accessory pathways)
- amiodarone usage within the past 3 months,
- unwillingness to participate or undergo insertable monitor implantation
- life expectancy \< 18 months
- currently pregnant or nursing a child
- unwilling not to become pregnant and to use birth control while taking spironolactone
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Piedmont Heart Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.