Effect of Dapagliflozin on Right Ventricular-Pulmonary Artery Coupling After Off-Pump Coronary Atery Bypass Grafting (DAPA-RV-CABG)

Effect of Dapagliflozin on Right Ventricular-Pulmonary Artery Coupling After Off-Pump Coronary Artery Bypass Grafting: a Prospective Single-Center Study

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Coronary Arterial Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 72

Contacts and Locations

• Study Contact: Name: Samson S. Badalyan, MD, PhD; Phone Number: +79614972949; Email: sambadalyan@mail.ru
• Study Contact Backup: Name: Syune V. Markosyan, MD.; Phone Number: +79633876510; Email: ssm8883@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with LVEF below 50% undergoing elective isolated off-pump coronary artery bypass grafting at a single center.

Description

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
• Clinical indication for dapagliflozin according to current guidelines (heart failure with reduced or mildly reduced ejection fraction and/or type 2 diabetes mellitus)
• Sinus rhythm at the time of each echocardiographic examination
• Written informed consent

Exclusion Criteria:

• Concomitant valve surgery
• Emergency or urgent CABG
• Conversion to on-pump during surgery
• Perioperative myocardial infarction
• Cardiogenic shock
• Atrial fibrillation or atrial flutter at any time during the study period
• More than moderate valvular heart disease
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Dapagliflozin Group; Patients receiving dapagliflozin 10 mg once daily starting at 1 month after off-pump CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 19 mg/day)

Secondary Outcome Measures

Outcome Measure	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)˄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)
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)

Collaborators and Investigators

• Sponsor: Samson Badalyan
• Investigators: Principal Investigator: Samson S. Badalyan, MD, PhD, City Clinical Hospital, Pyatigorsk, Russia

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dapagliflozin; CABG; SGLT2 inhibitor; OPCAB; Right Ventricle; Pulmonary vascular resistance; TAPSE/PASP; KCCQ-23; RV-PA coupling
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: DAPA-RV-CABG (Other Identifier: ClinicalTrials.gov PRS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data will be available upon reasonable request to the Principal Investigator after study completion and publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No