Back to resultsSpironolactone for Paroxysmal Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Spironolactone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, spironolactone
Eligibility Criteria
Inclusion criteria:
- 18 to 80 Y/O,
- Paroxysmal AF.
Exclusion criteria:
- GPT>100 IU/L or tota bilirubin >2 mg/dl;
- Creatinine > 2 mg/dl;
- Serum potassium >= 5 mM;
- Serum sodium <=130 mM;
- Uric acid > 10 mg/dl。
Sites / Locations
- Taichung General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
III
Experimental
Arm Description
Placebo
Drug intervention
Outcomes
Primary Outcome Measures
time to a first electrocardiographically confirmed AF
Secondary Outcome 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.
Full Information
NCT ID
NCT00689598
First Posted
March 30, 2008
Last Updated
June 4, 2008
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00689598
Brief Title
Spironolactone for Paroxysmal Atrial Fibrillation
Official Title
Use of Spironolactone to Treat Patients With Paroxysmal Atrial Fibrillation- A Multi-Center, Prospective, Randomized, Placebo-Controlled, Double Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
March 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, spironolactone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
III
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Drug intervention
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Other Intervention Name(s)
Aldactone
Intervention Description
25 mg po qd 25 mg po bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Aldactone
Intervention Description
Spironolactone 25 mg po qd
Primary Outcome Measure Information:
Title
time to a first electrocardiographically confirmed AF
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
18 to 80 Y/O,
Paroxysmal AF.
Exclusion criteria:
GPT>100 IU/L or tota bilirubin >2 mg/dl;
Creatinine > 2 mg/dl;
Serum potassium >= 5 mM;
Serum sodium <=130 mM;
Uric acid > 10 mg/dl。
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tsu-Juey Wu, M.D.
Phone
886-4-23592525
Ext
4043
Email
tjwu@vghtc.vghtc.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsu-Juey Wu, M.D.
Organizational Affiliation
TCVGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsu-Juey Wu, M.D.
Phone
886-4-23592525
Ext
4043
Email
tjwu@vghtc.vghtc.gov.tw
12. IPD Sharing Statement
Learn more about this trial
Spironolactone for Paroxysmal Atrial Fibrillation
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