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出境医 / 临床实验 / Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation
Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| AFib | Drug: Spironolactone Drug: No Spironolactone | Early Phase 1 |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized, pilot study |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | April 24, 2019 |
| Estimated Primary Completion Date : | May 2022 |
| Estimated Study Completion Date : | May 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Standard Therapy
subjects undergoing CTI ablation
|
Drug: No Spironolactone
no spironolactone treatment
|
|
Experimental: Interventional Therapy
subjects treated with an aldosterone antagonist after CTI ablation
|
Drug: Spironolactone
receive spironolactone treatment after CTI ablation
|
Outcome Measures
Primary Outcome Measures :
- 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)
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Contacts and Locations
Contacts
| Contact: Bola Ajose | 404-605-2875 | Bola.Ajose@piedmont.org | |
| Contact: Julia Daugherty | 404-605-2301 | Julia.Daugherty@piedmont.org |
Locations
| United States, Georgia | |
| Piedmont Heart Institute | Recruiting |
| Atlanta, Georgia, United States, 30309 | |
Sponsors and Collaborators
Piedmont Healthcare
Investigators
| Principal Investigator: | Bruce Stambler, MD | Piedmont Healthcare |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 24, 2019 | ||||||||
| First Posted Date ICMJE | April 29, 2019 | ||||||||
| Last Update Posted Date | September 30, 2020 | ||||||||
| Actual Study Start Date ICMJE | April 24, 2019 | ||||||||
| Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. | ||||||||
| 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 Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Early Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized, pilot study Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE | AFib | ||||||||
| Intervention ICMJE |
|
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| Study Arms ICMJE |
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
50 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | May 2022 | ||||||||
| Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03929718 | ||||||||
| Other Study ID Numbers ICMJE | AVOID-AF | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Piedmont Healthcare | ||||||||
| Study Sponsor ICMJE | Piedmont Healthcare | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
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| PRS Account | Piedmont Healthcare | ||||||||
| Verification Date | September 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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