Atrial Fibrillation (AF)NCT06740786
Efficacy and Safety of Dapagliflozin in Preventing Atrial Fibrillation Recurrence After Catheter Ablation
A study testing Dapagliflozin Treatment Group in people with Atrial Fibrillation (AF), run by Xu Liu.
Trial summary
Atrial fibrillation (AF) is a common arrhythmia, particularly prevalent in the elderly population. Catheter ablation is a common treatment for AF, but post-ablation recurrence of arrhythmias remains a significant clinical challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Dapagliflozin Treatment Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Patients aged 18 years and older. Presence of type 2 diabetes or heart failure. Diagnosis of Atrial Fibrillation: Confirmed atrial fibrillation through ECG or Holter monitoring.
- First-time Catheter Ablation: Patients undergoing their first atrial fibrillation catheter ablation.
- Voluntary Participation: Patients willing to participate and sign informed consent.
Who cannot join
- Presence of urinary tract infection Pregnancy or Breastfeeding: Women who are pregnant, breastfeeding, or planning to become pregnant.
- Allergy to Dapagliflozin or Similar Drugs: History of allergic reactions to dapagliflozin or other SGLT2 inhibitors.
- Other Contraindications to Dapagliflozin: Any other contraindications for dapagliflozin use.
- Kidney Function: eGFR < 45 ml/min/1.73m², with severe kidney disease.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Atrial fibrillation (AF) is a common arrhythmia, particularly prevalent in the elderly population. Catheter ablation is a common treatment for AF, but post-ablation recurrence of arrhythmias remains a significant clinical challenge. Dapagliflozin, an SGLT2 inhibitor primarily used for the treatment of type 2 diabetes, has shown potential in the field of cardiology, particularly for treating heart failure patients. Some studies suggest that dapagliflozin may reduce cardiac workload, improve heart function, and could even help in the management of atrial fibrillation. Therefore, this study aims to explore whether dapagliflozin can reduce the recurrence of arrhythmias following atrial fibrillation catheter ablation.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Dapagliflozin Treatment Group
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin Treatment GroupDrug
This group of patients will receive dapagliflozin treatment after undergoing atrial fibrillation catheter ablation.
Treatment regimen: Dapagliflozin will be administered orally once daily at the recommended dose (e.g., 10 mg/day).
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | This group of patients will receive placebo treatment. Receives: Drug: Dapagliflozin Treatment Group |
| treatment group | Experimental | Dapagliflozin will be administered orally once daily at the recommended dose (e.g., 10 mg/day). Receives: Drug: Dapagliflozin Treatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence of atrial arrhythmias
The recurrence of atrial arrhythmias within 12 months as assessed by ECG and holter, beyond the 3-month blanking period.
Measured: Within 12 months, beyond the 3-month blanking period.
Secondary outcomes (4)
The recurrence of atrial fibrillation
The recurrence of atrial fibrillation within 12 months as assessed by ECG and holter, beyond the 3-month blanking period.
Measured: Within 12 months, beyond the 3-month blanking period.
changes in quality of life at 12 months as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire
Quality of life was assessed using the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire, measuring changes from baseline to 12 months post-ablation.
Measured: 12 months post-ablation.
Atrial Fibrillation Burden
Atrial fibrillation burden is defined as the percentage of time spent in atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) detected by a 7-day single-lead ECG patch monitoring after 1 year post-ablation.
Measured: after 1 year post-ablation
Number of participants with adverse events
The safety of dapagliflozin assessed by researchers, including hypoglycemia, Urinary Tract Infections, dehydration and Hypotension,Acute Kidney Injury, diabetic ketoacidosi, cardiovascular events, severe allergic reactions, severe electrolyte Imbalance,etc.
Measured: 12 months post-ablation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start10 Dec 2024 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Hefei Binhu Hospital, The First People's Hospital of Hefei, Second People's Hospital of Hefei City, The Second People's Hospital of Anhui Province
- Responsible party
- Sponsor-investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740786
- Sponsor's protocol ID
- DAPAF
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dapagliflozin in Preventing Atrial Fibrillation Recurrence After Catheter Ablation
- ClinicalTrials.gov ID
- NCT06740786
- Acronym / sponsor ID
- DAPAF
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Xu LiuUniversity, hospital or other
- Collaborators
- Hefei Binhu Hospital, The First People's Hospital of Hefei, Second People's Hospital of Hefei City, The Second People's Hospital of Anhui Province
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 18 Dec 2024 (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.
Atrial fibrillation (AF) is a common arrhythmia, particularly prevalent in the elderly population. Catheter ablation is a common treatment for AF, but post-ablation recurrence of arrhythmias remains a significant clinical challenge. Dapagliflozin, an SGLT2 inhibitor primarily used for the treatment of type 2 diabetes, has shown potential in the field of cardiology, particularly for treating heart failure patients. Some studies suggest that dapagliflozin may reduce cardiac workload, improve heart function, and could even help in the management of atrial fibrillation. Therefore, this study aims to explore whether dapagliflozin can reduce the recurrence of arrhythmias following atrial fibrillation catheter ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Dapagliflozin Treatment GroupThis group of patients will receive placebo treatment. |
| treatment group | Experimental | Drug: Dapagliflozin Treatment GroupDapagliflozin will be administered orally once daily at the recommended dose (e.g., 10 mg/day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: Patients aged 18 years and older. Presence of type 2 diabetes or heart failure. Diagnosis of Atrial Fibrillation: Confirmed atrial fibrillation through ECG or Holter monitoring.
- First-time Catheter Ablation: Patients undergoing their first atrial fibrillation catheter ablation.
- Voluntary Participation: Patients willing to participate and sign informed consent.
Key exclusion criteria (4 listed)
- Presence of urinary tract infection Pregnancy or Breastfeeding: Women who are pregnant, breastfeeding, or planning to become pregnant.
- Allergy to Dapagliflozin or Similar Drugs: History of allergic reactions to dapagliflozin or other SGLT2 inhibitors.
- Other Contraindications to Dapagliflozin: Any other contraindications for dapagliflozin use.
- Kidney Function: eGFR < 45 ml/min/1.73m², with severe kidney disease.
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 |
|---|---|---|
| Dapagliflozin Treatment GroupThis group of patients will receive dapagliflozin treatment after undergoing atrial fibrillation catheter ablation. Treatment regimen: Dapagliflozin will be administered orally once daily at the recommended dose (e.g., 10 mg/day). | Drug | control group, treatment group |
Primary outcome
The recurrence of atrial arrhythmias
Time frame: Within 12 months, beyond the 3-month blanking period.
The recurrence of atrial arrhythmias within 12 months as assessed by ECG and holter, beyond the 3-month blanking period.
4 secondary outcomes
The recurrence of atrial fibrillation
Time frame: Within 12 months, beyond the 3-month blanking period.
changes in quality of life at 12 months as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire
Time frame: 12 months post-ablation.
Atrial Fibrillation Burden
Time frame: after 1 year post-ablation
Number of participants with adverse events
Time frame: 12 months post-ablation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Dapagliflozin Treatment Group in people with Atrial Fibrillation (AF), run by Xu Liu.
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 4 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: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shao Hui Wu, Doctor (+86 15821960839, wushaohui18@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recurrence of atrial arrhythmias (time frame: Within 12 months, beyond the 3-month blanking period.). 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 18 Dec 2024.