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Diabetes Mellitus, Type 2Phase 4NCT05621551

Dapagliflozin Therapy In Cardiac Surgery

A Phase 4 study testing Dapagliflozin in people with Diabetes Mellitus, Type 2 and Cardiac Surgery, run by China National Center for Cardiovascular Diseases at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2, Cardiac Surgery
What is being tested?
Dapagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
1 siteChina
Study dates
11 Nov 2022to 1 Jun 2025
Phase
Phase 4
Are there results?
None posted in the registry

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

Who may be able to join

  • Age ≥ 18 years at screening
  • Scheduled for cardiac surgery (on-pump coronary artery bypass grafting, aortic valve replacement, or a combination of both)
  • Diagnosis of Type 2 Diabetes
  • Provision of signed informed consent prior to any study specific procedures

Who cannot join

  • Emergency surgery and non-primary surgery
  • Moderate and severe dehydration; systolic pressure≤90mmHg; unstable haemodynamics
  • History of diabetic ketoacidosis; type 1 diabetes mellitus
  • Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment
  • Known allergy or hypersensitivity to dapagliflozin or other SGLT-2 inhibitors
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 or requiring dialysis; unstable or rapidly progressing renal disease at the time of randomisation
Show all 9Show fewer
  • Serious hepatic disease
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial
  • Currently enrolled in another investigational drug study, or less than 30 days

Trial locations and contacts

1 site in 1 country.

China1 site

  • National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100037

Other trials in China

About this study

Official title: Effects of Perioperative Dapagliflozin on Type 2 Diabetic Patients Undergoing Cardiac Surgery

This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery

Read the detailed description

Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2i) including dapagliflozin are widely used in the clinical treatment of type 2 diabetes mellitus(T2DM). In recent studies, SGLT2i were found to not only reduce blood glucose but also protect the heart and kidney, which can significantly reduce cardiovascular events, delay the progression of renal failure, greatly improve the quality of life of patients. Patients with T2DM have poorer cardiac surgery outcomes compared with non-diabetics. Based on the promising pharmacological profile of dapagliflozin, we hypothesize that perioperative dapagliflozin therapy would improve postoperative outcomes among patients undergoing cardiac surgery with T2DM. This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery

Being tested
Dapagliflozin
Keywords
SGLT2 inhibitors, Cardiac Surgery, Diabetes Mellitus
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DapagliflozinDrug

    The patients is required to receive dapagliflozin(10mg, q.d.) at least for 3 days until 24 hours before the surgery. Then dapagliflozin will be discontinued and recovered as soon as the patient is able to take oral diet postoperatively. Dapagliflozin wil be ceased five days after surgery.

Study groups in NCT05621551
Study groupRoleWhat they receive
DapagliflozinExperimentalDapagliflozin 10 mg
Receives: Drug: Dapagliflozin
Standard of careNo interventionStandard care treatment of diabetes patients during perioperative cardiac surgery in our center

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hs-Troponin-I

    high sensitive cardiac troponin-I

    Measured: within 2 days after surgery

Secondary outcomes (12)

  1. Renal function

    Acute kidney injury determined by creatinine changes and the need for renal replacement therapy, along with creatinine changes and the need for renal replacement therapy themselves.

    Measured: within 5 days after surgery

  2. NT-proBNP

    N-terminal prohormone of brain natriuretic peptide

    Measured: within 5 days after surgery

  3. Postoperative atrial fibrillation

    In this study, postoperative AF was defined as occurrence of the arrhythmia within the first 5 days after cardiac surgery. AF was considered to be present when an irregular rhythm was detected in the absence of P waves and/or presence an f wave

    Measured: within 5 days after surgery

  4. Perioperative myocardial infarction

    Perioperative myocardial infarction was defined as an elevation in cardiac troponin accompanied by evidence of ischemia from ECG, angiographic, or imaging findings.

    Measured: In-hospital time, an average of 2 weeks

  5. cardiac systolic function

    Improvement in either left ventricular ejection fraction or left ventricular end-systolic volume, as measured by echocardiography.

    Measured: within 5 days after surgery

  6. cardiac diastolic function

    Improvement in either E/e' ratio or left ventricular end-diastolic volume, as measured by echocardiography.

    Measured: within 5 days after surgery

  7. Abnormal blood potassium concentration

    blood potassium concentration<3.5mmol/L or >5.5mmol/L

    Measured: within 5 days after surgery

  8. postoperative blood glucose level

    Measured: within 5 days after surgery

  9. Inflammatory biomarkers

    high-sensitivity C-reactive protein, interleukin-1β, interleukin-6, interleukin-8, and tumor necrosis factor-α

    Measured: within 5 days after surgery

  10. Hs-Troponin-I

    Measured: within 5 days after surgery

  11. ICU stay

    ICU Stay was defined as the duration (in days) of initial postoperative stay in the intensive care unit following cardiac surgery.

    Measured: an average of 3 days

  12. Length of in-hospital time

    Length of in-hospital time was defined as the total number of days from the date of surgery to the date of hospital discharge.

    Measured: an average of 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2022
  2. Study start11 Nov 2022
  3. Primary completion1 Jun 2024
  4. Study completion1 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05621551
Sponsor's protocol ID
2021-1437
Status last verified
Jul 2025
First submitted
4 Nov 2022
Last updated
15 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin in people with Diabetes Mellitus, Type 2 and Cardiac Surgery, run by China National Center for Cardiovascular Diseases at 1 site in China.

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 9 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: finished, as of the sponsor's last update on 15 Jul 2025. 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 China. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hs-Troponin-I (time frame: within 2 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05621551.

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 15 Jul 2025.

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