Heart FailureDAPA-RV-CABGNCT07601867
Effect of Dapagliflozin on Right Ventricular-Pulmonary Artery Coupling After Off-Pump Coronary Atery Bypass Grafting
An observational study of Heart Failure and Coronary Arterial Disease, run by Pyatigorsk City Clinical Hospital Number 1 at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Coronary Arterial Disease
- How many people
- 72 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2026to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with LVEF below 50% undergoing elective isolated off-pump coronary artery bypass grafting at a single center.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Pyatigorsk City Clinical Hospital Number 1
Pyatigorsk, Stavropol Kray, 357500
Samson S. Badalyan, MD, PhD, +79614972949, sambadalyan@mail.ru
About this study
Official title: 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).
Read the detailed description
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.
- Conditions
- Heart Failure, Coronary Arterial Disease
- Keywords
- OPCAB, Right Ventricle, SGLT2 inhibitor, Dapagliflozin, TAPSE/PASP, Pulmonary vascular resistance, KCCQ-23, CABG, RV-PA coupling
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin Group | Patients receiving dapagliflozin 10 mg once daily starting at 1 month after off-pump CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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)
Measured: 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)
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)
Measured: 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)
Change in Left Ventricular Ejection Fraction (LVEF)
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)
Measured: 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pyatigorsk City Clinical Hospital Number 1
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Samson Badalyan, Pyatigorsk City Clinical Hospital Number 1
- Investigators
- Samson S. Badalyan, MD, PhD, Principal investigator, Pyatigorsk City Clinical Hospital Number 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601867
- Sponsor's protocol ID
- DAPA-RV-CABG
- Other IDs
- DAPA-RV-CABG
- Acronym
- DAPA-RV-CABG
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will be available upon reasonable request to the Principal Investigator after study completion and publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dapagliflozin on Right Ventricular-Pulmonary Artery Coupling After Off-Pump Coronary Artery Bypass Grafting: a Prospective Single-Center Study
- ClinicalTrials.gov ID
- NCT07601867
- Acronym / sponsor ID
- DAPA-RV-CABG / DAPA-RV-CABG
- Conditions
- Heart Failure, Coronary Arterial Disease
- Keywords
- OPCAB, Right Ventricle, SGLT2 inhibitor, Dapagliflozin, TAPSE/PASP, Pulmonary vascular resistance, KCCQ-23, CABG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Pyatigorsk City Clinical Hospital Number 1Other government
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin Group | – | –Patients receiving dapagliflozin 10 mg once daily starting at 1 month after off-pump CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with LVEF below 50% undergoing elective isolated off-pump coronary artery bypass grafting at a single center.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
6 secondary outcomes
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)
Change in Pulmonary Vascular Resistance (PVR)
Time frame: 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)
Change in NT-proBNP Levels
Time frame: 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)
Time frame: 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)
Time frame: 1 month after surgery (before dapagliflozin) to 7 months after surgery (after 6 months of dapagliflozin)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data will be available upon reasonable request to the Principal Investigator after study completion and publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samson S. Badalyan, MD, PhD principal investigator
Pyatigorsk City Clinical Hospital Number 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Coronary Arterial Disease, run by Pyatigorsk City Clinical Hospital Number 1 at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samson S. Badalyan, MD, PhD (+79614972949, sambadalyan@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.