NCT07601867

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
23mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Jul 2028

First Submitted

Initial submission to the registry

May 12, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

June 17, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

May 12, 2026

Last Update Submit

June 15, 2026

Conditions

Heart FailureCoronary Arterial Disease

Keywords

OPCABRight VentricleSGLT2 inhibitorDapagliflozinTAPSE/PASPPulmonary vascular resistanceKCCQ-23CABGRV-PA coupling

Outcome Measures

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)

    1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin 10 mg/day)

Secondary Outcomes (6)

  • Change in Pulmonary Artery Systolic Pressure (PASP)

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

  • Change in Pulmonary Vascular Resistance (PVR)

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

  • Change in NT-proBNP Levels

    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)

    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)

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

  • +1 more secondary outcomes

Study Arms (1)

Dapagliflozin Group

Patients receiving dapagliflozin 10 mg once daily starting at 1 month after off-pump CABG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pyatigorsk City Clinical Hospital Number 1

Pyatigorsk, Stavropol Kray, 357500, Russia

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Samson S. Badalyan, MD, PhD

    Pyatigorsk City Clinical Hospital Number 1

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samson S. Badalyan, MD, PhD

CONTACT

+79614972949sambadalyan@mail.ru

Syune V. Markosyan, MD.

CONTACT

+79633876510ssm8883@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist, Principal Investigator

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 22, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

June 17, 2026

Record last verified: 2026-05

Locations

RU(1)