Spironolactone for Paroxysmal Atrial Fibrillation - Tabular View

Tracking Information

First Received Date ^ICMJE

March 30, 2008

Last Updated Date

June 4, 2008

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

time to a first electrocardiographically confirmed AF [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00689598 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Spironolactone for Paroxysmal Atrial Fibrillation

Official Title ^ICMJE

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

Brief Summary

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

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Drug: Spironolactone
Drug: Placebo

Study Arms / Comparison Groups

Placebo Comparator: Placebo
Experimental: Drug intervention

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2011

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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。

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Tsu-Juey Wu, M.D.

886-4-23592525 ext 4043

tjwu@vghtc.vghtc.gov.tw

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT ID ^ICMJE

NCT00689598

Responsible Party

Tsu-Juey Wu, M.D./Staff Physician, Taichung Veterans General Hospital

Study ID Numbers ^ICMJE

C07061

Study Sponsor ^ICMJE

Taichung Veterans General Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Tsu-Juey Wu, M.D.

TCVGH

Information Provided By

Taichung Veterans General Hospital

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP