NCT00689598

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 5, 2008

Status Verified

June 1, 2008

Enrollment Period

3 years

First QC Date

March 30, 2008

Last Update Submit

June 4, 2008

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, spironolactone

Outcome Measures

Primary Outcomes (1)

  • time to a first electrocardiographically confirmed AF

    3 months

Secondary Outcomes (1)

  • 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

Study Arms (2)

III

PLACEBO COMPARATOR

Placebo

Drug: Spironolactone

Experimental

EXPERIMENTAL

Drug intervention

Drug: SpironolactoneDrug: Placebo

Interventions

SpironolactoneDRUG

25 mg po qd 25 mg po bid

Also known as: Aldactone
ExperimentalIII
PlaceboDRUG

Spironolactone 25 mg po qd

Also known as: Aldactone
Experimental

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 80 Y/O,
  • Paroxysmal AF.

You may not qualify if:

  • 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。

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung General Hospital

Taichung, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Tsu-Juey Wu, M.D.

    TCVGH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsu-Juey Wu, M.D.

CONTACT

886-4-23592525tjwu@vghtc.vghtc.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2008

First Posted

June 3, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

June 5, 2008

Record last verified: 2008-06

Locations

TW(1)