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| ID | Type | Description | Link |
|---|---|---|---|
| DAPA-RV-CABG | Other Identifier | ClinicalTrials.gov PRS |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin Group | Patients receiving dapagliflozin 10 mg once daily starting at 1 month after off-pump CABG |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin 10 mg/day) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulmonary Artery Systolic Pressure (PASP) | The change in pulmonary artery systolic pressure (PASP) calculated as 4 x (TR Vmax)Ë„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) | 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with LVEF below 50% undergoing elective isolated off-pump coronary artery bypass grafting at a single center.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samson S. Badalyan, MD, PhD | Contact | +79614972949 | sambadalyan@mail.ru | |
| Syune V. Markosyan, MD. | Contact | +79633876510 | ssm8883@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Samson S. Badalyan, MD, PhD | Pyatigorsk City Clinical Hospital Number 1 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pyatigorsk City Clinical Hospital Number 1 | Recruiting | Pyatigorsk | Stavropol Kray | 357500 | Russia |
Individual participant data will be available upon reasonable request to the Principal Investigator after study completion and publication
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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) | 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin) |
| 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) | 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin) |
| 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) | 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin) |
| Change in Right Ventricular Fractional Area Change (RV FAC) | 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) | 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin) |
| Change in Left Ventricular Ejection Fraction (LVEF) | 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) | 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin) |