AFibEarly Phase 1NCT03929718
Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation
A Early Phase 1 study testing Spironolactone and No Spironolactone in people with AFib, run by Piedmont Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AFib
- What is being tested?
- Spironolactone and No Spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to Sep 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Catheter ablation of the cavotricuspid isthmus (CTI) is an effective and safe procedure in patients with atrial flutter (AFL) with excellent long-term results in preventing AFL recurrences. However, new-onset atrial fibrillation (AF) commonly develops after this procedure and has important clinical implications for patient management. Few studies have assessed the long-term incidence and prevalence of AF after CTI ablation via intensive continuous rhythm monitoring with an implantable cardiac monitor. Furthermore, whether the development of AF can be impacted beneficially by adjunctive therapeutic approaches is not known. The co-primary objectives of this pilot study in patients with typical atrial flutter (AFL) but no previously detected AF are: 1) to accurately determine the long-term incidence of new-onset AF after CTI ablation using an implantable rhythm monitor; 2) to compare the rates of new onset AF in subjects randomized to standard, usual-care, medical therapy following CTI ablation compared with those randomized to treatment with an aldosterone antagonist (spironolactone) in addition to their usual care medications. The patient population will be subjects with typical atrial flutter and a history of hypertension or heart failure, but no known AF episodes, scheduled to undergo catheter ablation of the CTI for treatment of AFL. Patients will be randomized to remain on their standard, usual-care. medications or to take oral spironolactone (a standard, FDA-approved medication used in the treatment of hypertension and heart failure) starting after their ablation procedure. The primary study endpoint will be any atrial tachyarrhythmia episode (AF, AFL or atrial tachycardia) lasting greater than one minute detected via the implanted cardiac monitor after CTI ablation during long-term follow-up. The incidence of new-onset AF after CTI ablation will be compared between subjects randomized to be treated with usual care vs. those treated with usual care plus spironolactone on an intention to treat basis.
- Conditions
- AFib
- Being tested
- Spironolactone, No Spironolactone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
receive spironolactone treatment after CTI ablation
No SpironolactoneDrug
no spironolactone treatment
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | Active comparator | subjects undergoing CTI ablation Receives: Drug: No Spironolactone |
| Interventional Therapy | Experimental | subjects treated with an aldosterone antagonist after CTI ablation Receives: Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-Term incidence of new-onset AF after CTI ablation
- To accurately determine the long-term incidence of new-onset AF after CTI ablation using an implantable rhythm monitor
Measured: 24 months
Rates of new-onset AF between standard therapy and spironolactone
- 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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start24 Apr 2019
- Primary completionSep 2025 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AFibStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, pilot study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Piedmont Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce Stambler, MD, Principal investigator, Piedmont Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929718
- Sponsor's protocol ID
- AVOID-AF
- Status last verified
- May 2025
- First submitted
- 24 Apr 2019
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03929718
- Acronym / sponsor ID
- AVOID-AF
- Conditions
- AFib
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Piedmont HealthcareUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Catheter ablation of the cavotricuspid isthmus (CTI) is an effective and safe procedure in patients with atrial flutter (AFL) with excellent long-term results in preventing AFL recurrences. However, new-onset atrial fibrillation (AF) commonly develops after this procedure and has important clinical implications for patient management. Few studies have assessed the long-term incidence and prevalence of AF after CTI ablation via intensive continuous rhythm monitoring with an implantable cardiac monitor. Furthermore, whether the development of AF can be impacted beneficially by adjunctive therapeutic approaches is not known. The co-primary objectives of this pilot study in patients with typical atrial flutter (AFL) but no previously detected AF are: 1) to accurately determine the long-term incidence of new-onset AF after CTI ablation using an implantable rhythm monitor; 2) to compare the rates of new onset AF in subjects randomized to standard, usual-care, medical therapy following CTI ablation compared with those randomized to treatment with an aldosterone antagonist (spironolactone) in addition to their usual care medications. The patient population will be subjects with typical atrial flutter and a history of hypertension or heart failure, but no known AF episodes, scheduled to undergo catheter ablation of the CTI for treatment of AFL. Patients will be randomized to remain on their standard, usual-care. medications or to take oral spironolactone (a standard, FDA-approved medication used in the treatment of hypertension and heart failure) starting after their ablation procedure. The primary study endpoint will be any atrial tachyarrhythmia episode (AF, AFL or atrial tachycardia) lasting greater than one minute detected via the implanted cardiac monitor after CTI ablation during long-term follow-up. The incidence of new-onset AF after CTI ablation will be compared between subjects randomized to be treated with usual care vs. those treated with usual care plus spironolactone on an intention to treat basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, pilot study
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | Active comparator | Drug: No Spironolactonesubjects undergoing CTI ablation |
| Interventional Therapy | Experimental | Drug: Spironolactonesubjects treated with an aldosterone antagonist after CTI ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spironolactonereceive spironolactone treatment after CTI ablation | Drug | Interventional Therapy |
| No Spironolactoneno spironolactone treatment | Drug | Standard Therapy |
Primary outcome
Long-Term incidence of new-onset AF after CTI ablation
Time frame: 24 months
1. To accurately determine the long-term incidence of new-onset AF after CTI ablation using an implantable rhythm monitor
Rates of new-onset AF between standard therapy and spironolactone
Time frame: 24 months
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Stambler, MD principal investigator
Piedmont Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Spironolactone and No Spironolactone in people with AFib, run by Piedmont Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-Term incidence of new-onset AF after CTI ablation (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.