Atrial Fibrillation RecurrencePhase 4DETAIL-CMIVNCT05816733
Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure
A Phase 4 study testing Dapagliflozin in people with Atrial Fibrillation Recurrence and Cox Maze IV, run by Kun Hua at 1 site in China.
Trial summary
Atrial fibrillation (AF) is the most common arrhythmia, which leads to reduced cardiac output and promotes the occurrence of heart failure, and abnormal hemodynamic changes in the left atrium induce thrombosis, which seriously reduces the quality of life, and even leads to death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation Recurrence, Cox Maze IV, Atrial Fibrillation
- What is being tested?
- Dapagliflozin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 7 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Patients with persistent or long-term persistent atrial fibrillation who need isolated surgical Cox-Maze IV procedure
- Patients who need cardiac surgery combined with Cox-Maze IV procedure
- Patients who have the ability and willingness to abide by all the subsequent reviews and requirements
- Sign the informed consent
Who cannot join
- Dapagliflozin allergy
- Hyperthyroidism
- Patients with acute myocardial infarction, cerebral apoplexy, and other vascular diseases during the past 6 months
- Patients who received heart surgery within the last 3 months
- eGFR<45ml/min
- History of oral SGLT2i
Show all 10Show fewer
- Estimated survival period < 12 months
- Pregnant and lactating women
- Left atrial diameter > 65 mm
- Refusing to sign the informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cardiac Surgery Center No. 7
Beijing, Beijing Municipality, 100029
zhan peng, 01064456776, anzhen0607@126.com
Hua Kun
About this study
Official title: Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure: Prospective Randomized Trial (DETAIL-CMIV)
Atrial fibrillation (AF) is the most common arrhythmia, which leads to reduced cardiac output and promotes the occurrence of heart failure, and abnormal hemodynamic changes in the left atrium induce thrombosis, which seriously reduces the quality of life, and even leads to death. For patients who need cardiac surgery combined with the Cox-Maze IV (CMIV) surgical ablation, oral amiodarone postoperatively for three consecutive months was recommended as the preferred treatment option. However, the study found there were still 15%-35% of patients at risk of AF recurrence. Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, has been widely used for the treatment of type 2 diabetes mellitus and heart failure. Nonetheless, it remains unknown whether dapagliflozin can improve the recurrence of AF and reduces adverse cardiovascular events for patients who need CMIV ablation, and whether it can be routinely used for AF patients without diabetes or heart failure. Therefore, this study aims to explore the effect of postoperative oral dapagliflozin on the recurrence of AF after CMIV.
- Conditions
- Atrial Fibrillation Recurrence, Cox Maze IV, Atrial Fibrillation, Patients With or Without Heart Failure and Diabetes
- Being tested
- Dapagliflozin, Placebo
- Medical subject headings
- Atrial Fibrillation, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Patients randomized in this arm will receive dapagliflozin at a target dose of 10mg once daily and routine treatment.
PlaceboDrug
Patients randomized in this arm will receive placebo at a target dose of 10mg once daily and routine treatment.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin group | Experimental | Patients who will be randomized to receive dapagliflozin following the Cox-Maze IV Procedure. Receives: Drug: Dapagliflozin |
| Placebo group | Placebo comparator | Patients who will be randomized to receive placebo following the Cox-Maze IV Procedure. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of atrial fibrillation recurrence
Measured: half of one year post operative
Secondary outcomes (2)
Rate of atrial fibrillation recurrence
Measured: one year post operative
Cardiovascular complex adverse events
cardiogenic death, new onset heart failure, malignant arrhythmias, stroke
Measured: one year post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Sep 2023
- Primary completion7 Jun 2024 (estimated)
- Study completion7 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation RecurrenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kun Hua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kun Hua, Beijing Anzhen Hospital
- Investigators
- Kun Hua, Study director, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816733
- Sponsor's protocol ID
- KS2023017
- Acronym
- DETAIL-CMIV
- Status last verified
- Nov 2023
- First submitted
- 2 Apr 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure: Prospective Randomized Trial (DETAIL-CMIV)
- ClinicalTrials.gov ID
- NCT05816733
- Acronym / sponsor ID
- DETAIL-CMIV / KS2023017
- Conditions
- Atrial Fibrillation Recurrence, Cox Maze IV, Atrial Fibrillation, Patients With or Without Heart Failure and Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Kun HuaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 7 Jun 2024 (estimated)
- Study completion
- 7 Aug 2024 (estimated)
- First posted
- 18 Apr 2023 (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 the most common arrhythmia, which leads to reduced cardiac output and promotes the occurrence of heart failure, and abnormal hemodynamic changes in the left atrium induce thrombosis, which seriously reduces the quality of life, and even leads to death. For patients who need cardiac surgery combined with the Cox-Maze IV (CMIV) surgical ablation, oral amiodarone postoperatively for three consecutive months was recommended as the preferred treatment option. However, the study found there were still 15%-35% of patients at risk of AF recurrence. Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, has been widely used for the treatment of type 2 diabetes mellitus and heart failure. Nonetheless, it remains unknown whether dapagliflozin can improve the recurrence of AF and reduces adverse cardiovascular events for patients who need CMIV ablation, and whether it can be routinely used for AF patients without diabetes or heart failure. Therefore, this study aims to explore the effect of postoperative oral dapagliflozin on the recurrence of AF after CMIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin group | Experimental | Drug: DapagliflozinPatients who will be randomized to receive dapagliflozin following the Cox-Maze IV Procedure. |
| Placebo group | Placebo comparator | Drug: PlaceboPatients who will be randomized to receive placebo following the Cox-Maze IV Procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Patients with persistent or long-term persistent atrial fibrillation who need isolated surgical Cox-Maze IV procedure
- Patients who need cardiac surgery combined with Cox-Maze IV procedure
- Patients who have the ability and willingness to abide by all the subsequent reviews and requirements
- Sign the informed consent
Key exclusion criteria (10 listed)
- Dapagliflozin allergy
- Hyperthyroidism
- Patients with acute myocardial infarction, cerebral apoplexy, and other vascular diseases during the past 6 months
- Patients who received heart surgery within the last 3 months
- eGFR<45ml/min
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 |
|---|---|---|
| DapagliflozinPatients randomized in this arm will receive dapagliflozin at a target dose of 10mg once daily and routine treatment. | Drug | Dapagliflozin group |
| PlaceboPatients randomized in this arm will receive placebo at a target dose of 10mg once daily and routine treatment. | Drug | Placebo group |
Primary outcome
Rate of atrial fibrillation recurrence
Time frame: half of one year post operative
2 secondary outcomes
Rate of atrial fibrillation recurrence
Time frame: one year post operative
Cardiovascular complex adverse events
Time frame: one year post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Kun Hua study director
Beijing Anzhen Hospital
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 Dapagliflozin in people with Atrial Fibrillation Recurrence and Cox Maze IV, run by Kun Hua 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 5 inclusion and 10 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 29 Nov 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?
Contact Zhan Peng (010-64456776, anzhen0607@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of atrial fibrillation recurrence (time frame: half of one year post operative). 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 29 Nov 2023.