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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Dapagliflizon in Atrial fibrillation on Rythme controlActive comparator 1 intervention

Trial outcomes

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).

Time frame
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.

Time frame
9 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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