Spironolactone for Paroxysmal Atrial Fibrillation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Taichung Veterans General Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Taichung Veterans General Hospital
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT00689598
First received: March 30, 2008
Last updated: June 4, 2008
Last verified: June 2008
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Purpose
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 Endpoint Classification: Efficacy Study 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:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
Drug Information available for:
Spironolactone
U.S. FDA Resources
Further study details as provided by Taichung Veterans General Hospital:
Primary Outcome Measures:
- time to a first electrocardiographically confirmed AF [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
| 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
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
|
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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。
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689598
Please refer to this study by its ClinicalTrials.gov identifier: 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
| 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 |
| Health Authority: | Taiwan: Department of Health |
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 |
ClinicalTrials.gov processed this record on September 27, 2016