Spironolactone for Paroxysmal Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Use of Spironolactone to Treat Patients With Paroxysmal Atrial Fibrillation- A Multi-Center, Prospective, Randomized, Placebo-Controlled, Double Blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00689598
• Other study ID #: C07061
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2008
• Last updated: June 4, 2008
• Start date: March 2008
• Est. completion date: March 2011

Study information

• Verified date: June 2008
• Source: Taichung Veterans General Hospital
• Contact: Tsu-Juey Wu, M.D.
• Phone: 886-4-23592525
• Email: tjwu[@]vghtc.vghtc.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

To determine whether or not spironolactone can prevent or delay the occurrence of atrial fibrillation.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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?

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Spironolactone
25 mg po qd 25 mg po bid
• Placebo
Spironolactone 25 mg po qd

Locations

Country	Name	City	State
Taiwan	Taichung General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to a first electrocardiographically confirmed AF		3 months	No
Secondary	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.		3 months	No