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
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
  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:


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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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。
  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

No publications provided

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
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014