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Spironolactone for Paroxysmal Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT00689598
Recruitment Status : Unknown
Verified June 2008 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
First Posted : June 3, 2008
Last Update Posted : June 5, 2008
Sponsor:
Information provided by:
Taichung Veterans General Hospital

Tracking Information
First Submitted Date  ICMJE March 30, 2008
First Posted Date  ICMJE June 3, 2008
Last Update Posted Date June 5, 2008
Study Start Date  ICMJE March 2008
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2008)
time to a first electrocardiographically confirmed AF [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2008)
1. Response rate: Improvement of any symptom scores and/or SF36 scores more than 50 % (compared with re-randomization scores) 2. Difference of mean episodes of documented AF between the spironolactone and placebo groups. [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spironolactone for Paroxysmal Atrial Fibrillation
Official Title  ICMJE Use of Spironolactone to Treat Patients With Paroxysmal Atrial Fibrillation- A Multi-Center, Prospective, Randomized, Placebo-Controlled, Double Blind Study
Brief Summary To determine whether or not spironolactone can prevent or delay the occurrence of atrial fibrillation.
Detailed Description To determine whether or not adding spironolactone can prevent or delay the occurrence of paroxysmal atrial fibrillation in patients who have received propafenone treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Drug: Spironolactone
    25 mg po qd 25 mg po bid
    Other Name: Aldactone
  • Drug: Placebo
    Spironolactone 25 mg po qd
    Other Name: Aldactone
Study Arms  ICMJE
  • Placebo Comparator: III
    Placebo
    Intervention: Drug: Spironolactone
  • Experimental: Experimental
    Drug intervention
    Interventions:
    • Drug: Spironolactone
    • Drug: Placebo
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 2, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2011
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. 18 to 80 Y/O,
  2. Paroxysmal AF.

Exclusion criteria:

  1. GPT>100 IU/L or tota bilirubin >2 mg/dl;
  2. Creatinine > 2 mg/dl;
  3. Serum potassium >= 5 mM;
  4. Serum sodium <=130 mM;
  5. Uric acid > 10 mg/dl。
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00689598
Other Study ID Numbers  ICMJE C07061
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tsu-Juey Wu, M.D./Staff Physician, Taichung Veterans General Hospital
Study Sponsor  ICMJE Taichung Veterans General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tsu-Juey Wu, M.D. TCVGH
PRS Account Taichung Veterans General Hospital
Verification Date June 2008

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