Atrial FibrillationPhase 4DORISNCT05655468
Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation
A Phase 4 study testing Dronedarone in people with Atrial Fibrillation, run by Shanghai East Hospital at 1 site in China.
Trial summary
Recurrence rate remains high after radiofrequency ablation in patients with non-paroxysmal atrial fibrillation(AF). Prolonged use of anti-arrhythmic drugs (AAD) beyond the post-ablation blanking has been adopted as a solution but without sufficient clinical evidence. 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?
- Dronedarone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2023to Nov 2025
- Phase
- Phase 4
- 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
- Aged 18-80 years;
- Diagnosis of non-paroxysmal AF
- Undergoing AF ablation for the first time
Who cannot join
- Unwilling to take or intolerant to dronedarone;
- Hypersensitivity to the drug ingredient
- Patients with decompensated heart failure, class NYHA IV, or left ventricular ejection fraction (LVEF) ≤40%
- Bradycardia <50 bpm
- QTc Bazett interval ≥500ms or PR interval >280ms
- II or III atrioventricular (AV) block or sick-sinus syndrome without permanent pacemaker
Show all 20Show fewer
- Diagnosed with acute coronary syndrome or treated with percutaneous coronary intervention within the last 3 months
- Patients with structural heart disease (moderate to severe aortic or mitral valve stenosis, interventricular septal thickness >15mm, congenital heart disease)
- Accepted cardiac surgery within the last 3 months
- Left atrial diameter (LAD) >55 mm
- Patients with left atrial or left auricular thrombosis
- Patients with Hyperthyroidism
- Severe dysfunction of liver and kidney diseases (ALT≥3ULN or eGFR<30ml/min/1.73m2)
- Abnormal blood coagulation
- Concomitant use of dabigatran
- Concomitant use of drugs that prolong QTc or may induce torsades de pointes
- Concomitant use of strong CYP3A inhibitors
- Concomitant use of another Class IA, IC, or III AADs
- Patients suffering from serious infection, mental illness or malignant tumors
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai
Bing Yang, MD, +86-18117141291, ybheart@163.com
About this study
Recurrence rate remains high after radiofrequency ablation in patients with non-paroxysmal atrial fibrillation(AF). Prolonged use of anti-arrhythmic drugs (AAD) beyond the post-ablation blanking has been adopted as a solution but without sufficient clinical evidence. Dronedarone is an AAD valid to maintain sinus rhythm and has fewer side effect than other AAD for long-term use.We sought to investigate the effect of prolonged use of dronedarone on recurrence of non-paroxysmal AF patients beyond the post-blanking period within the first year after ablation.
Read the detailed description
In this multicenter, randomized, placebo-controlled trial, patients with non-paroxysmal AF will receive dronedarone for three months after radiofrequency ablation. Eligible Patients will then be randomly divided into dronedarone and placebo groups and followed up until one year after ablation. The primary endpoint is the cumulative nonrecurrence rate post three months and within one year after ablation. 7-day Holter monitoring (ECG patch) will be scheduled at 6,9, and 12 months after ablation for evaluating AA recurrence. Secondary endpoints include dronedarone withdrawal due to side effect or intolerance of AA recurrence, time to the first recurrence, repeat ablation, electrical cardioversion, unscheduled visit ,and rehospitalization.
This trial will evaluate whether prolonged use of dronedarone effectively reduces recurrence rate after ablation in non-paroxysmal AF patients. The result of this trial will provide evidence for optimizing post-ablation anti-arrhythmic therapy.
- Conditions
- Atrial Fibrillation
- Being tested
- Dronedarone, Placebo
- Keywords
- dronedarone, placebo, non-paroxysmal atrial fibrillation, ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronedaroneDrug
oral administration fed conditions
PlaceboDrug
strictly identical in appearance with dronedarone,oral administration fed conditions
| Study group | Role | What they receive |
|---|---|---|
| dronedarone | Experimental | dronedarone 400mg twice a day for 9 months Receives: Drug: Dronedarone |
| placebo | Placebo comparator | Placebo(for dronedarone ) a day for 9 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative nonrecurrence rate
defined as any atrial tachyarrhythmias (including atrial fibrillation, atrial flutter, or atrial tachycardia) recorded by electrocardiogram (ECG)>30s
Measured: post 3 to 12 months after ablation
Secondary outcomes (6)
drug withdrawal because of side effect
Measured: post 3 to 12 months after ablation
drug withdrawal due to intolerance to or persistent AA(lasting more than 7 days)
Measured: post 3 to 12 months after ablation
time to first recurrence
Measured: post 3 to 12 months after ablation
cardioversion due to recurrence
Measured: post 3 to 12 months after ablation
repeat ablation due to recurrence
Measured: post 3 to 12 months after ablation
unscheduled visit and rehospitalization due to recurrence
Measured: post 3 to 12 months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start29 Mar 2023
- Primary completionApr 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Bing, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655468
- Sponsor's protocol ID
- DFLC2022011
- Acronym
- DORIS
- Status last verified
- Apr 2023
- First submitted
- 7 Dec 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu Y, Fan F, Yu J, Zhou J, Xie X, Xia G, Zhong D, Cheng D, Zhang B, Wang X, Chen Z, Wang S, Li X, Yang B. Effect of Prolonged Use of Dronedarone on Recurrence in Patients with Non-Paroxysmal Atrial Fibrillation After Radiofrequency Ablation (DORIS): Rationale and Design of a Randomized Multicenter, Double-Blinded Placebo-Controlled Trial. Cardiovasc Drugs Ther. 2024 Oct;38(5):1047-1052. doi: 10.1007/s10557-023-07460-1. Epub 2023 May 8.
PubMed 37155004
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT05655468
- Acronym / sponsor ID
- DORIS / DFLC2022011
- Conditions
- Atrial Fibrillation
- Keywords
- dronedarone, placebo, non-paroxysmal atrial fibrillation, ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 19 Dec 2022 (actual)
- 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.
Recurrence rate remains high after radiofrequency ablation in patients with non-paroxysmal atrial fibrillation(AF). Prolonged use of anti-arrhythmic drugs (AAD) beyond the post-ablation blanking has been adopted as a solution but without sufficient clinical evidence. Dronedarone is an AAD valid to maintain sinus rhythm and has fewer side effect than other AAD for long-term use.We sought to investigate the effect of prolonged use of dronedarone on recurrence of non-paroxysmal AF patients beyond the post-blanking period within the first year after ablation.
Detailed description
In this multicenter, randomized, placebo-controlled trial, patients with non-paroxysmal AF will receive dronedarone for three months after radiofrequency ablation. Eligible Patients will then be randomly divided into dronedarone and placebo groups and followed up until one year after ablation. The primary endpoint is the cumulative nonrecurrence rate post three months and within one year after ablation. 7-day Holter monitoring (ECG patch) will be scheduled at 6,9, and 12 months after ablation for evaluating AA recurrence. Secondary endpoints include dronedarone withdrawal due to side effect or intolerance of AA recurrence, time to the first recurrence, repeat ablation, electrical cardioversion, unscheduled visit ,and rehospitalization.
This trial will evaluate whether prolonged use of dronedarone effectively reduces recurrence rate after ablation in non-paroxysmal AF patients. The result of this trial will provide evidence for optimizing post-ablation anti-arrhythmic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dronedarone | Experimental | Drug: Dronedaronedronedarone 400mg twice a day for 9 months |
| placebo | Placebo comparator | Drug: PlaceboPlacebo(for dronedarone ) a day for 9 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-80 years;
- Diagnosis of non-paroxysmal AF
- Undergoing AF ablation for the first time
Key exclusion criteria (20 listed)
- Unwilling to take or intolerant to dronedarone;
- Hypersensitivity to the drug ingredient
- Patients with decompensated heart failure, class NYHA IV, or left ventricular ejection fraction (LVEF) ≤40%
- Bradycardia <50 bpm
- QTc Bazett interval ≥500ms or PR interval >280ms
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 |
|---|---|---|
| Dronedaroneoral administration fed conditions | Drug | dronedarone |
| Placebostrictly identical in appearance with dronedarone,oral administration fed conditions | Drug | placebo |
Primary outcome
cumulative nonrecurrence rate
Time frame: post 3 to 12 months after ablation
defined as any atrial tachyarrhythmias (including atrial fibrillation, atrial flutter, or atrial tachycardia) recorded by electrocardiogram (ECG)>30s
6 secondary outcomes
drug withdrawal because of side effect
Time frame: post 3 to 12 months after ablation
drug withdrawal due to intolerance to or persistent AA(lasting more than 7 days)
Time frame: post 3 to 12 months after ablation
time to first recurrence
Time frame: post 3 to 12 months after ablation
cardioversion due to recurrence
Time frame: post 3 to 12 months after ablation
repeat ablation due to recurrence
Time frame: post 3 to 12 months after ablation
unscheduled visit and rehospitalization due to recurrence
Time frame: post 3 to 12 months after ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Derived from this study: PubMed 37155004Wu Y, Fan F, Yu J, Zhou J, Xie X, Xia G, Zhong D, Cheng D, Zhang B, Wang X, Chen Z, Wang S, Li X, Yang B. Effect of Prolonged Use of Dronedarone on Recurrence in Patients with Non-Paroxysmal Atrial Fibrillation After Radiofrequency Ablation (DORIS): Rationale and Design of a Randomized Multicenter, Double-Blinded Placebo-Controlled Trial. Cardiovasc Drugs Ther. 2024 Oct;38(5):1047-1052. doi: 10.1007/s10557-023-07460-1. Epub 2023 May 8.
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Atrial Fibrillation (AF)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dronedarone in people with Atrial Fibrillation, run by Shanghai East Hospital at 1 site in China.
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 3 inclusion and 20 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 13 Apr 2023. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative nonrecurrence rate (time frame: post 3 to 12 months after ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05655468, which also lists 1 linked publication.
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 13 Apr 2023.