Effect of Dapagliflozin on Right Ventricular-Pulmonary Artery Coupling After Off-Pump Coronary Atery Bypass Grafting

N/ANot Yet RecruitingNCT07601867

Pyatigorsk City Clinical Hospital Number 172 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Failure Coronary Arterial Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Change in TAPSE/PASP Ratio

The change in the ratio of tricuspid annular plane systolic excursion (TAPSE) to pulmonary artery pressure (PASP) from 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin 10 mg/day)

Time frame: 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin 10 mg/day)

Secondary Outcomes

Change in Pulmonary Artery Systolic Pressure (PASP)

The change in pulmonary artery systolic pressure (PASP) calculated as 4 x (TR Vmax)˄2 + estimated right atrial pressure (RAP) from 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin 10 mg/day)