Dapagliflozin on Outcomes of Rhythm Control Strategy (Pharmacological ± Interventional) in Patient with Atrial Fibrillation

NCT06759909 | Not Yet Recruiting Phase 1

• 1 other identifier: Dapagliflozin in AF Patients
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dapagliflozin (Forxiga); Atrial Fibrillation (AF)

Keywords

dapagliflozin; rythme control

Outcome Measures

Primary Outcomes (1)

• 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).

  9 month

Secondary Outcomes (1)

• cardiovascular hospitalization

  9 month

Study Arms (1)

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.

Drug: Dapagliflozin (DAPA)

Interventions

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.

Dapagliflizon in Atrial fibrillation on Rythme control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 38484841 BACKGROUND

• Luo 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.

  PMID: 35962156 BACKGROUND

• Pluymaekers 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.

  PMID: 30883054 BACKGROUND

• Packer 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.

  PMID: 30874766 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hanan Gamal, master student

CONTACT

+20 1013751813; hanangamal314@gmail.com

salah Ata, cardiologist

CONTACT

+20 1091318801

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident physician of cardiology

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 6, 2025
• Study Start: January 3, 2025
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 22, 2028
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share