About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Adult patients with LVEF below 50% undergoing elective isolated off-pump coronary artery bypass grafting at a single center.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial 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)
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)
Change in Pulmonary Vascular Resistance (PVR)
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
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)
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)
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