Effect of Dapagliflozin on Right Ventricular-Pulmonary Artery Coupling After Off-Pump Coronary Atery Bypass Grafting (DAPA-RV-CABG)
15 juni 2026 uppdaterad 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).
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
72
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Samson S. Badalyan, MD, PhD
- Telefonnummer: +79614972949
- E-post: sambadalyan@mail.ru
Studera Kontakt Backup
- Namn: Syune V. Markosyan, MD.
- Telefonnummer: +79633876510
- E-post: ssm8883@gmail.com
Studieorter
-
-
Stavropol Kray
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Pyatigorsk, Stavropol Kray, Ryssland, 357500
- Rekrytering
- Pyatigorsk City Clinical Hospital Number 1
-
Kontakt:
- Samson S. Badalyan, MD, PhD
- Telefonnummer: +79614972949
- E-post: sambadalyan@mail.ru
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Adult patients with LVEF below 50% undergoing elective isolated off-pump coronary artery bypass grafting at a single center.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Dapagliflozin Group
Patients receiving dapagliflozin 10 mg once daily starting at 1 month after off-pump CABG
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in TAPSE/PASP Ratio
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Pulmonary Artery Systolic Pressure (PASP)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Samson S. Badalyan, MD, PhD, Pyatigorsk City Clinical Hospital Number 1
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 maj 2028
Avslutad studie (Beräknad)
1 juli 2028
Studieregistreringsdatum
Först inskickad
12 maj 2026
Först inskickad som uppfyllde QC-kriterierna
18 maj 2026
Första postat (Faktisk)
22 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 juni 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DAPA-RV-CABG (Annan identifierare: ClinicalTrials.gov PRS)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
IPD-planbeskrivning
Individual participant data will be available upon reasonable request to the Principal Investigator after study completion and publication
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