Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07601867

Effect of Dapagliflozin on Right Ventricular-Pulmonary Artery Coupling After Off-Pump Coronary Atery Bypass Grafting

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).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pyatigorsk City Clinical Hospital Number 1

Pyatigorsk, Stavropol Kray, 357500, Russia

Location status: Recruiting

Location contact

Samson S. Badalyan, MD, PhD

CONTACT

[email protected]

+79614972949

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

    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

  1. 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)

    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)

  2. Change in Pulmonary Vascular Resistance (PVR)

    Time frame: 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)

    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)

  3. Change in NT-proBNP Levels

    Time frame: 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)

    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)

  4. 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)

    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)

  5. 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)

    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)

  6. 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)

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Samson S. Badalyan, MD, PhD

CONTACT

[email protected]

+79614972949

Syune V. Markosyan, MD.

CONTACT

[email protected]

+79633876510

Sponsors and collaborators

Lead sponsor

Pyatigorsk City Clinical Hospital Number 1

Other Gov

Registry information

Official study title

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

Acronym: DAPA-RV-CABG

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 22, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.