Spironolactone for Paroxysmal Atrial Fibrillation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2008 by Taichung Veterans General Hospital.
Recruitment status was: Recruiting

Sponsor:

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

History of Changes

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 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

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 ]

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 ]


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)
Sexes Eligible for Study:	All
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

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

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 21, 2017

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