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Spironolactone for Paroxysmal Atrial Fibrillation

Information source: Taichung Veterans General Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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
Last updated: June 4, 2008

Page last updated: February 07, 2013

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