Spironolactone for Paroxysmal Atrial Fibrillation

Verified by: Taichung Veterans General Hospital, June 2008
First Received: March 30, 2008 | Last Updated: June 4, 2008 | Phase: N/A | Start Date: March 2008
Overall Status: Recruiting | Estimated Enrollment: 30
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To determine whether or not spironolactone can prevent or delay the occurrence of atrial fibrillation...

Brief Summary

Official Title: “Use of Spironolactone to Treat Patients With Paroxysmal Atrial Fibrillation- A Multi-Center, Prospective, Randomized, Placebo-Controlled, Double Blind Study”

To determine whether or not spironolactone can prevent or delay the occurrence of atrial fibrillation.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: March 2011

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Drug: Spironolactone
    • 25 mg po qd 25 mg po bid
  • Drug: Placebo
    • Spironolactone 25 mg po qd

Arms, Groups and Cohorts in this Clinical Trial

  • Placebo Comparator: III
    • Placebo
  • Experimental: Experimental
    • Drug intervention

Outcome Measures for this Clinical Trial

Primary Measures

  • time to a first electrocardiographically confirmed AF
    • Time Frame: 3 months
      Safety Issue?: No

Secondary Measures

  • 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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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。

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Taichung Veterans General Hospital Other

Overall Clinical Trial Officials and Contacts

Tsu-Juey Wu, M.D. Principal Investigator TCVGH  

Overall Contact: Tsu-Juey Wu, M.D. 886-4-23592525 tjwu@vghtc.vghtc.gov.tw

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00689598

Study ID Number: C07061

ClinicalTrials.gov Identifier: NCT00689598

Health Authority: Taiwan: Department of Health

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00689598