Spironolactone for Paroxysmal Atrial Fibrillation - Full Text View

Sponsored by:	Taichung Veterans General Hospital
Information provided by:	Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:	NCT00689598

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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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: Brugada syndrome familial atrial fibrillation short QT syndrome

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
III: Placebo Comparator Placebo	Drug: Spironolactone 25 mg po qd 25 mg po bid
Experimental: Experimental Drug intervention	Drug: Spironolactone 25 mg po qd 25 mg po bid Drug: Placebo Spironolactone 25 mg po qd

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
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

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

No publications provided

Responsible Party:	Taichung Veterans General Hospital ( Tsu-Juey Wu, M.D./Staff Physician )
Study ID Numbers:	C07061
Study First Received:	March 30, 2008
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00689598 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by Taichung Veterans General Hospital:

Atrial fibrillation, spironolactone

Study placed in the following topic categories:

Heart Diseases
Aldosterone Antagonists
Hormone Antagonists
Diuretics
Hormones, Hormone Substitutes, and Hormone Antagonists

Cardiovascular Agents
Atrial Fibrillation
Hormones
Spironolactone
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Heart Diseases
Hormone Antagonists
Diuretics
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Agents
Pharmacologic Actions
Spironolactone

Pathologic Processes
Aldosterone Antagonists
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on July 02, 2009