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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPyatigorsk City Clinical Hospital Number 1

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

72 Participants
are grouped into 1 trial group
Group A: Dapagliflozin Group

Trial outcomes

Primary outcomes

1

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)

Time frame
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)

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)

Time frame
1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)
2

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)

Time frame
1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)
3

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)

Time frame
1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)
4

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)

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

Other outcomes

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