Evaluating dapagliflozin for patients with atrial fibrillation after heart surgery
Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure: Prospective Randomized Trial (DETAIL-CMIV)
This study is testing if the diabetes and heart failure medication dapagliflozin can help people with atrial fibrillation feel better and have fewer heart problems after heart surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 348 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Anzhen Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05816733 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of dapagliflozin, a medication commonly used for diabetes and heart failure, on patients with atrial fibrillation who are undergoing the Cox-Maze IV surgical procedure. It aims to determine whether dapagliflozin can reduce the recurrence of atrial fibrillation and improve cardiovascular outcomes compared to a placebo. The study includes patients aged 18 and older who have persistent atrial fibrillation and are scheduled for the surgery, while excluding those with certain health conditions or recent surgeries. Participants will be monitored for their response to the treatment over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with persistent or long-term persistent atrial fibrillation requiring the Cox-Maze IV procedure.
Not a fit: Patients with recent heart surgery, severe renal impairment, or certain cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to reduce atrial fibrillation recurrence and improve quality of life for patients undergoing heart surgery.
How similar studies have performed: While dapagliflozin has shown benefits in diabetes and heart failure, its specific application for atrial fibrillation post-surgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Estimated survival period \< 12 months * Pregnant and lactating women * Left atrial diameter \> 65 mm * Refusing to sign the informed consent
Where this trial is running
Beijing, Beijing
- Cardiac Surgery Center No. 7 — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Zhan Peng
- Email: anzhen0607@126.com
- Phone: 010-64456776
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.