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Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT03929718
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Piedmont Healthcare

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.

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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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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)



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929718


Contacts
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Contact: Bola Ajose 404-605-2875 Bola.Ajose@piedmont.org
Contact: Julia Daugherty 404-605-2301 Julia.Daugherty@piedmont.org

Locations
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United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Piedmont Healthcare
Investigators
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Principal Investigator: Bruce Stambler, MD Piedmont Healthcare

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Responsible Party: Piedmont Healthcare
ClinicalTrials.gov Identifier: NCT03929718     History of Changes
Other Study ID Numbers: AVOID-AF
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents