Dapagliflozin (Forxiga)Phase 1NCT06759909
Dapagliflozin on Outcomes of Rhythm Control Strategy (Pharmacological ± Interventional) in Patient with Atrial Fibrillation
A Phase 1 study testing Dapagliflozin (DAPA) in people with Dapagliflozin (Forxiga) and Atrial Fibrillation (AF), run by Assiut University.
Trial summary
Investigator study the efficacy and safety outcomes of Dapagliflozin use among newly diagnosed Atrial fibrillation patients when underwent rhythm control strategy regardless their diabetic status. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dapagliflozin (Forxiga), Atrial Fibrillation (AF)
- What is being tested?
- Dapagliflozin (DAPA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2025to 22 Dec 2028
- Phase
- Phase 1
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed AF patients (Time between AF diagnosis to rhythm control attempt less than one year) Paroxysmal and persistent atrial fibrillation (AF) documented on a 12 lead ECG, Holter monitor (episodes of AF must be >30 seconds in duration to qualify as an inclusion criterion) Age of 18 years or older on the date of consent. Informed Consent
Who cannot join
- Long standing persistent AF. Previous use of dapagliflozin within one month of rhythm control attempt. Previous rhythm control attempt. AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery). History of congestive heart failure. Active intracardiac thrombus Pre-existing pulmonary vein stenosis or pulmonary vein stent Contraindication to anticoagulation or radio contrast materials
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
salah Ata, cardiologist contact
About this study
Official title: Influence of Use of Dapagliflozin on Outcomes of Rhythm Control Strategy (Pharmacological ± Interventional) in Patient with Atrial Fibrillation
Investigator study the efficacy and safety outcomes of Dapagliflozin use among newly diagnosed Atrial fibrillation patients when underwent rhythm control strategy regardless their diabetic status.
Read the detailed description
Atrial fibrillation (AF) is the most common arrhythmia among adults with increasing risk of stroke, heart failure (HF) and mortality .
Based on the EAST-AFNET 4 trial and nationwide cohort studies, early rhythm control treatment (Antiarrhythmic drugs AAD or catheter ablation) was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients who had recently (within one year) been diagnosed with atrial fibrillation A new oral hypoglycemic drug, dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), was confirmed to reduce the risk of cardiovascular adverse events (AEs) and improve coronary heart disease and HF outcomes in multiple clinical trials . In addition, previous post hoc analyses and meta-analyses reported that dapagliflozin can decrease the incidence rate of new-onset AF Recent trials and meta-analyses have reported that SGLT2i can achieve greater suppression of AF recurrence after catheter ablation (CA) in T2DM patients . Nonetheless, it remains unknown whether dapagliflozin can improve the recurrence of AF among newly diagnosed AF patients who underwent rhythm control strategy regardless the diabetic status.
- Conditions
- Dapagliflozin (Forxiga), Atrial Fibrillation (AF)
- Being tested
- Dapagliflozin (DAPA)
- Keywords
- dapagliflozin, rythme control
- 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 (DAPA)Drug
We will record all baseline characteristics (Age, sex, BMI, HR and BP), AF type, EHRA class, previous use of ADD (B blockers, Class I, III AAD), previous CV, prior cerebrovascular stroke and Co-morbidities (HTN, DM, IHD, HF, Renal impairment, peripheral arterial disease, OSAS). CHADS2Vasc score and HAS-BLEED score will be calculated. Trans-thoracic echocardiograms will be performed within 4 weeks before the rhythm control attempts to determine LA diameter and volumes and left ventricular hypertrophy and functions (EF and E/'e).
After enrollment, the patients will be treated with dapagliflozin (10 mg/d) or placebo at the time of rhythm control strategy and will continue daily treatment at the same dose till the 9 month follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflizon in Atrial fibrillation on Rythme control | Active comparator | investigator study the efficacy and safety outcomes of Dapagliflozin use among newly diagnosed AF patients when underwent rhythm control strategy regardless their diabetic status.
After enrollment, the patients will be treated with dapagliflozin (10 mg/d) or placebo at the time of rhythm control strategy and will continue daily treatment at the same dose till the 9 month follow-up period. Receives: Drug: Dapagliflozin (DAPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
freedom from any atrial arrhythmia
The primary effectiveness endpoint is freedom from any atrial arrhythmia (atrial arrhythmia defined as Atrial fibrillation or atrial tachycardia [AT] that lasted ≥ 30 seconds on/off AAD detected by the monitoring tools during the follow-up period excluding the first three months of the blanking period).
Measured: 9 month
Secondary outcomes (1)
cardiovascular hospitalization
Cardiovascular hospitalizations are defined as any hospitalizations due to cardiovascular cause such as AF related hospitalizations (such as emergency department (ED) visits, repeat ablation, electrical cardioversion and AV nodal ablation), device implantations, and decompensated HF hospitalization, stroke, myocardial infarction, vascular complications and major bleedings.
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start3 Jan 2025 (estimated)
- Primary completion22 Dec 2026 (estimated)
- Study completion22 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dapagliflozin (Forxiga)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Gamal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759909
- Sponsor's protocol ID
- Dapagliflozin in AF Patients
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stachteas P, Karakasis P, Karagiannidis E, Patoulias D, Athanasiadou P, Nasoufidou A, Papadopoulos C, Kassimis G, Fragakis N. Efficacy of sodium-glucose cotransporter 2 inhibitors in preventing atrial fibrillation recurrence after catheter ablation. Hellenic J Cardiol. 2024 Sep-Oct;79:86-87. doi: 10.1016/j.hjc.2024.03.008. Epub 2024 Mar 12. No abstract available.
PubMed 38484841Luo F, Sun L, Wang Z, Zhang Y, Li J, Chen Y, Dong J. Effect of Dapagliflozin on the Outcome of Radiofrequency Catheter Ablation in Patients with Type 2 Diabetes Mellitus and Atrial Fibrillation. Cardiovasc Drugs Ther. 2024 Feb;38(1):91-98. doi: 10.1007/s10557-022-07368-2. Epub 2022 Aug 13.
PubMed 35962156Pluymaekers NAHA, Dudink EAMP, Luermans JGLM, Meeder JG, Lenderink T, Widdershoven J, Bucx JJJ, Rienstra M, Kamp O, Van Opstal JM, Alings M, Oomen A, Kirchhof CJ, Van Dijk VF, Ramanna H, Liem A, Dekker LR, Essers BAB, Tijssen JGP, Van Gelder IC, Crijns HJGM; RACE 7 ACWAS Investigators. Early or Delayed Cardioversion in Recent-Onset Atrial Fibrillation. N Engl J Med. 2019 Apr 18;380(16):1499-1508. doi: 10.1056/NEJMoa1900353. Epub 2019 Mar 18.
PubMed 30883054Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Poole JE, Noseworthy PA, Rosenberg YD, Jeffries N, Mitchell LB, Flaker GC, Pokushalov E, Romanov A, Bunch TJ, Noelker G, Ardashev A, Revishvili A, Wilber DJ, Cappato R, Kuck KH, Hindricks G, Davies DW, Kowey PR, Naccarelli GV, Reiffel JA, Piccini JP, Silverstein AP, Al-Khalidi HR, Lee KL; CABANA Investigators. Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1261-1274. doi: 10.1001/jama.2019.0693.
PubMed 30874766