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

15. juni 2026 oppdatert av: Samson Badalyan, Pyatigorsk City Clinical Hospital Number 1

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).

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

72

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Syune V. Markosyan, MD.
  • Telefonnummer: +79633876510
  • E-post: ssm8883@gmail.com

Studiesteder

  • Russland
    • Stavropol Kray
      • Pyatigorsk, Stavropol Kray, Russland, 357500
        • Rekruttering
        • Pyatigorsk City Clinical Hospital Number 1
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in TAPSE/PASP Ratio
Tidsramme: 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)
1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin 10 mg/day)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Pulmonary Artery Systolic Pressure (PASP)
Tidsramme: 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)
1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)
Change in Pulmonary Vascular Resistance (PVR)
Tidsramme: 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)
1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)
Change in NT-proBNP Levels
Tidsramme: 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)
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)
Tidsramme: 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)
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)
Tidsramme: 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)
1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)
Change in Left Ventricular Ejection Fraction (LVEF)
Tidsramme: 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)
1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pyatigorsk City Clinical Hospital Number 1

Etterforskere

  • Hovedetterforsker: Samson S. Badalyan, MD, PhD, Pyatigorsk City Clinical Hospital Number 1

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. mai 2028

Studiet fullført (Antatt)

1. juli 2028

Datoer for studieregistrering

Først innsendt

12. mai 2026

Først innsendt som oppfylte QC-kriteriene

18. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DAPA-RV-CABG (Annen identifikator: ClinicalTrials.gov PRS)

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

IPD-planbeskrivelse

Individual participant data will be available upon reasonable request to the Principal Investigator after study completion and publication

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