Spironolactone for Paroxysmal Atrial Fibrillation
Information source: Taichung Veterans General Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Spironolactone (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Taichung Veterans General Hospital Official(s) and/or principal investigator(s):
Tsu-Juey Wu, M.D., Principal Investigator, Affiliation: TCVGH
Overall contact:
Tsu-Juey Wu, M.D., Phone: 886-4-23592525, Ext: 4043, Email: tjwu@vghtc.vghtc.gov.tw
Summary
To determine whether or not spironolactone can prevent or delay the occurrence of atrial
fibrillation.
Clinical Details
Official title: Use of Spironolactone to Treat Patients With Paroxysmal Atrial Fibrillation- A Multi-Center, Prospective, Randomized, Placebo-Controlled, Double Blind Study
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: time to a first electrocardiographically confirmed AF
Secondary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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。
Locations and Contacts
Tsu-Juey Wu, M.D., Phone: 886-4-23592525, Ext: 4043, Email: tjwu@vghtc.vghtc.gov.tw
Taichung General Hospital, Taichung 40705, Taiwan; Recruiting
Tsu-Juey Wu, M.D., Phone: 886-4-23592525, Ext: 4043, Email: tjwu@vghtc.vghtc.gov.tw
Additional Information
Starting date: March 2008
Ending date: March 2011
Last updated: June 4, 2008
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