Coronary Arterial Disease, Heart Failure
Conditions
Keywords
OPCAB, Right Ventricle, SGLT2 inhibitor, Dapagliflozin, TAPSE/PASP, Pulmonary vascular resistance, KCCQ-23, CABG, RV-PA coupling
Brief summary
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).
Detailed description
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.
Interventions
None listed
Sponsors
Pyatigorsk City Clinical Hospital Number 1
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in TAPSE/PASP Ratio | 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin 10 mg/day) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulmonary Artery Systolic Pressure (PASP) | 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin) | 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) |
| Change in Pulmonary Vascular Resistance (PVR) | 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin) | The change in pulmonary vascular resistance (PVR) calculated as (TR Vmax / VTI RVOT) x 10 + 0.16 (wood units) from 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin 10 mg/day) |
| Change in NT-proBNP Levels | 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin) | The change in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels (pg/ml) from 1 month after surgery (before dapagliflozin) to 7 month after surgery (after 6 months of dapagliflozin 10 mg/day) |
| Change in Quality of Life (KCCQ-23 Overall Summary Score) | 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin) | The change in qulity of life assessed by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) Overall Summary Score (range 0 to 100), higher score indicates better quality of life) from 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin 10 mg/day) |
| Change in Right Ventricular Fractional Area Change (RV FAC) | 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin) | The change in right ventricular fractional area change (RV FAC) calculated as (RVEDA - RVESA) / RVEDA x 100 (%) from 1 month after surgery (before dapagliflozin) to 7 months after surgery ( after 6 months of dapagliflozin 10 mg/day) |
| Change in Left Ventricular Ejection Fraction (LVEF) | 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin) | The change in left ventricular ejection fraction (LVEF) calculated by biplane Simpson method (%) from 1 month after surgery (befiore dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin 10 mg/day) |
Countries
Russia
Contacts
CONTACTSamson S. Badalyan, MD, PhD
CONTACTSyune V. Markosyan, MD.
PRINCIPAL_INVESTIGATORSamson S. Badalyan, MD, PhD
Pyatigorsk City Clinical Hospital Number 1
Outcome results
None listed