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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2011

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

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

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

Lead Sponsor: Taichung Veterans General Hospital

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

Information obtained from ClinicalTrials.gov on July 02, 2009

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