Effect of Dapagliflozin on Right Ventricular-Pulmonary Artery Coupling After Off-Pump Coronary Atery Bypass Grafting
Recruiting · NCT07601867 · Observational (researchers observe without assigning treatment) · Lead sponsor: Pyatigorsk City Clinical Hospital Number 1
View the official record on ClinicalTrials.gov →What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Pyatigorsk City Clinical Hospital Number 1 - Pyatigorsk, Stavropol Kray, Russia