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Spironolactone for Paroxysmal Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT00689598
Recruitment Status : Unknown
Verified June 2008 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
First Posted : June 3, 2008
Last Update Posted : June 5, 2008
Sponsor:
Information provided by:
Taichung Veterans General Hospital

Study Description
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Brief Summary:
To determine whether or not spironolactone can prevent or delay the occurrence of atrial fibrillation.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Spironolactone Drug: Placebo Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Use of Spironolactone to Treat Patients With Paroxysmal Atrial Fibrillation- A Multi-Center, Prospective, Randomized, Placebo-Controlled, Double Blind Study
Study Start Date : March 2008
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: III
Placebo
 Drug: Spironolactone
25 mg po qd 25 mg po bid
Other Name: Aldactone
Experimental: Experimental
Drug intervention
 Drug: Spironolactone
25 mg po qd 25 mg po bid
Other Name: Aldactone

Drug: Placebo
Spironolactone 25 mg po qd
Other Name: Aldactone


Outcome Measures
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Primary Outcome Measures :
  1. time to a first electrocardiographically confirmed AF [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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。
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689598


Contacts
Contact: Tsu-Juey Wu, M.D. 886-4-23592525 ext 4043 tjwu@vghtc.vghtc.gov.tw

Locations
Taiwan
Taichung General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Tsu-Juey Wu, M.D.    886-4-23592525 ext 4043    tjwu@vghtc.vghtc.gov.tw   
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Principal Investigator: Tsu-Juey Wu, M.D. TCVGH
More Information
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Responsible Party: Tsu-Juey Wu, M.D./Staff Physician, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00689598     History of Changes
Other Study ID Numbers: C07061
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: June 5, 2008
Last Verified: June 2008

Keywords provided by Taichung Veterans General Hospital:
Atrial fibrillation, spironolactone

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Spironolactone
Mineralocorticoid Receptor Antagonists
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents