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Trial record 18 of 224 for:    Aldosterone

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

Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date April 29, 2019
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
 (submitted: April 24, 2019)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
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
Condition  ICMJE AFib
Intervention  ICMJE
  • Drug: Spironolactone
    receive spironolactone treatment after CTI ablation
  • Drug: No Spironolactone
    no spironolactone treatment
Study Arms  ICMJE
  • Active Comparator: Standard Therapy
    subjects undergoing CTI ablation
    Intervention: Drug: No Spironolactone
  • Experimental: Interventional Therapy
    subjects treated with an aldosterone antagonist after CTI ablation
    Intervention: Drug: Spironolactone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2019)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bola Ajose 404-605-2875 Bola.Ajose@piedmont.org
Contact: Julia Daugherty 404-605-2301 Julia.Daugherty@piedmont.org
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
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Piedmont Healthcare
Study Sponsor  ICMJE Piedmont Healthcare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruce Stambler, MD Piedmont Healthcare
PRS Account Piedmont Healthcare
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP