Effect of Dapagliflozin on Right Ventricular-Pulmonary Artery Coupling After Off-Pump Coronary Atery Bypass Grafting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure, Coronary Arterial Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Dapagliflozin on Right Ventricular-Pulmonary Artery Coupling After Off-Pump Coronary Artery Bypass Grafting: a Prospective Single-Center Study
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).
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.
Primary outcome measures
- Change in TAPSE/PASP Ratio [Time frame: 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin 10 mg/day)]
Secondary outcome measures (6)
- Change in Pulmonary Artery Systolic Pressure (PASP) [Time frame: 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)]
- Change in Pulmonary Vascular Resistance (PVR) [Time frame: 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)]
- Change in NT-proBNP Levels [Time frame: 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) [Time frame: 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) [Time frame: 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)]
- Change in Left Ventricular Ejection Fraction (LVEF) [Time frame: 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- Pyatigorsk City Clinical Hospital Number 1 — Pyatigorsk
Identifiers
NCT: NCT07601867 · DAPA-RV-CABG · DAPA-RV-CABG