Spironolactone for Paroxysmal Atrial Fibrillation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
First received: March 30, 2008
Last updated: June 4, 2008
Last verified: June 2008
To determine whether or not spironolactone can prevent or delay the occurrence of atrial fibrillation.

Condition Intervention
Atrial Fibrillation
Drug: Spironolactone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Taichung Veterans General Hospital:

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

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. [ Time Frame: 3 months ]

Estimated Enrollment: 30
Study Start Date: March 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: III
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

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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。
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00689598

Taichung General Hospital
Taichung, Taiwan, 40705
Sponsors and Collaborators
Taichung Veterans General Hospital
Principal Investigator: Tsu-Juey Wu, M.D. TCVGH
  More Information

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 
Study First Received: March 30, 2008
Last Updated: June 4, 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
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents

ClinicalTrials.gov processed this record on January 19, 2017