Atrial FibrillationNCT00689598
Spironolactone for Paroxysmal Atrial Fibrillation
A study testing Spironolactone in people with Atrial Fibrillation, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
To determine whether or not spironolactone can prevent or delay the occurrence of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Spironolactone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2008to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 Y/O,
- Paroxysmal AF.
Who cannot join
- 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。
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung General Hospital
Taichung, 40705
Tsu-Juey Wu, M.D., 886-4-23592525 ext. 4043, tjwu@vghtc.vghtc.gov.tw
About this study
Official title: Use of Spironolactone to Treat Patients With Paroxysmal Atrial Fibrillation- A Multi-Center, Prospective, Randomized, Placebo-Controlled, Double Blind Study
To determine whether or not spironolactone can prevent or delay the occurrence of atrial fibrillation.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Spironolactone, Placebo
- Keywords
- Atrial fibrillation, spironolactone
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
Also called Aldactone
25 mg po qd 25 mg po bid
PlaceboDrug
Also called Aldactone
Spironolactone 25 mg po qd
| Study group | Role | What they receive |
|---|---|---|
| III | Placebo comparator | Placebo Receives: Drug: Spironolactone |
| Experimental | Experimental | Drug intervention Receives: Drug: Spironolactone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to a first electrocardiographically confirmed AF
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tsu-Juey Wu, M.D., Principal investigator, TCVGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689598
- Sponsor's protocol ID
- C07061
- Status last verified
- Jun 2008
- First submitted
- 30 Mar 2008
- Last updated
- 5 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Spironolactone to Treat Patients With Paroxysmal Atrial Fibrillation- A Multi-Center, Prospective, Randomized, Placebo-Controlled, Double Blind Study
- ClinicalTrials.gov ID
- NCT00689598
- Acronym / sponsor ID
- C07061
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, spironolactone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| III | Placebo comparator | Drug: SpironolactonePlacebo |
| Experimental | Experimental | Drug: Spironolactone, Drug: PlaceboDrug intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 80 Y/O,
- Paroxysmal AF.
Key exclusion criteria (5 listed)
- 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。
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpironolactoneAlso: Aldactone25 mg po qd 25 mg po bid | Drug | Experimental, III |
| PlaceboAlso: AldactoneSpironolactone 25 mg po qd | Drug | Experimental |
Primary outcome
time to a first electrocardiographically confirmed AF
Time frame: 3 months
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsu-Juey Wu, M.D. principal investigator
TCVGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spironolactone in people with Atrial Fibrillation, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsu-Juey Wu, M.D. (886-4-23592525 ext. 4043, tjwu@vghtc.vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to a first electrocardiographically confirmed AF (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2008; AzTrials last refreshed its copy on 6 Nov 2026.