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

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 |
- time to a first electrocardiographically confirmed AF [ Time Frame: 3 months ]
- 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 ]

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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 |
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。

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
Contact: Tsu-Juey Wu, M.D. | 886-4-23592525 ext 4043 | tjwu@vghtc.vghtc.gov.tw |
Taiwan | |
Taichung General Hospital | Recruiting |
Taichung, Taiwan, 40705 | |
Contact: Tsu-Juey Wu, M.D. 886-4-23592525 ext 4043 tjwu@vghtc.vghtc.gov.tw |
Principal Investigator: | Tsu-Juey Wu, M.D. | TCVGH |
Responsible Party: | Tsu-Juey Wu, M.D./Staff Physician, Taichung Veterans General Hospital |
ClinicalTrials.gov Identifier: | NCT00689598 |
Other Study ID Numbers: |
C07061 |
First Posted: | June 3, 2008 Key Record Dates |
Last Update Posted: | June 5, 2008 |
Last Verified: | June 2008 |
Atrial fibrillation, spironolactone |
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 |