Effect of Dapagliflozin on Right Ventricular-Pulmonary Artery Coupling After Off-Pump Coronary Artery Bypass Grafting: a Prospective Single-Center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
研究概览
简要总结
This prospective, single-center observational study evaluates the effect of dapagliflozin 10 mg/day on right ventricular-pulmonary artery coupling measured by the TAPSE/PASP ratio in 72 patients with left ventricular ejection fraction <50% after off-pump coronary artery bypass grafting (OPCAB). The primary outcome is the change in TAPSE/PASP ratio from 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin therapy).
详细描述
Patients undergo echocardiography at three time points: pre-operatively (T0), at 1 month post-surgery before dapagliflozin initiation (T1), and at 7 months post-surgery after 6 months of dapagliflozin 10 mg/day (T2).
The primary objective is to evaluate the change in the TAPSE/PASP ratio from T1 to T2.
Secondary objectives are to evaluate changes from T1 to T2 in:
- Pulmonary artery systolic pressure (PASP)
- Pulmonary vascular resistance (PVR)
- Right ventricular fractional area change (RV FAC)
- Left ventricular ejection fraction (LVEF)
- NT-proBNP levels
- Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) overall summary score
The study aims to provide mechanistic insight into the effects of SGLT2 inhibition on right ventricular-pulmonary artery coupling after off-pump coronary artery bypass grafting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Elective isolated off-pump coronary artery bypass grafting (OPCAB)
- •Left ventricular ejection fraction (LVEF) < 50% documented on pre-operative echocardiography
- •Written informed consent
排除标准
- •Concomitant valve surgery
- •Emergency or urgent CABG
- •Conversion to on-pump during surgery
- •Perioperative myocardial infarction (as defined by the Fourth Universal Definition of MI)
- •Cardiogenic shock
- •More than moderate valvular heart disease
- •Persistent atrial fibrillation or atrial flutter at the time of echocardiographic examination)
- •Previous CABG or any prior cardiac surgery
- •Severe chronic kidney disease (eGFR < 25 mL/min/1.73 m²)
- •Contraindication to SGLT2 inhibitors
- •Inability to obtain adequate echocardiographic windows
- •Pregnancy or breastfeeding
研究组 & 干预措施
Dapagliflozin Group
Patients receiving dapagliflozin 10 mg once daily starting at 1 month after off-pump CABG
研究者
Samson Badalyan
Cardiologist, Principal Investigator
Pyatigorsk City Clinical Hospital Number 1