Perioperative ComplicationNCT06326528
SGLT2 Inhibitors and Perioperative Period
An observational study of Perioperative Complication, run by Assiut University.
Trial summary
The expanded use of SGLT2 inhibitors motivates us to assess the role of SGLT2 inhibitors in perioperative period on patients who will undergo cardiac surgery in Assiut University. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perioperative Complication
- What is being tested?
- SGLT2 inhibitor
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Oct 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cardiac patients prepared for cardiac surgery
Who may be able to join
- 1. All subjects with coronary artery disease or valvular heart disease referred to cardiac surgery
Who cannot join
- Congenital heart disease.
- Cardiomyopathy (EF>40%).
- Sever renal impairment (eGFR>30).
- COPD.
- Marked obesity (BMI<35).
- Previous cardiac surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Short Term Outcome of SGLT2 Inhibitors on Patients Who Undergo Cardiac Surgery in Perioperative Period
The expanded use of SGLT2 inhibitors motivates us to assess the role of SGLT2 inhibitors in perioperative period on patients who will undergo cardiac surgery in Assiut University.
Read the detailed description
With over 50 million cases of heart failure worldwide, heart failure is one of the most serious health issues facing humanity. Heart failure patients still have an extremely poor prognosis and quality of life, even with advancements in heart failure treatment. It continues to be the most common cause of hospitalization in elderly.
A substantial number of theories have been proposed to explain the beneficial effects of SGLT2 inhibitors. These include blood pressure lowering, increasing diuresis/natriuresis, improving cardiac energy metabolism, preventing inflammation, weight loss, improving glucose control, inhibiting the sympathetic nervous system, preventing adverse cardiac remodeling, preventing ischemia/reperfusion injury, inhibiting the cardiac Na/H exchanger inhibiting SGLT1, reducing hyperuricemia, increasing autophagy and lysosomal degradation, decreasing epicardial fat mass, increasing erythropoietin (EPO) levels, increasing circulating provascular progenitor cells, decreasing oxidative stress; and improving vascular function.
In addition to lowering blood sugar, several large trials also have demonstrated cardiovascular and renal benefits in patients with T2DM. Surprisingly, recent data also suggest that SGLT-2 inhibitors may improve cardiovascular and renal outcomes in patients without diabetes, leading to expanded indications for their use.
- Conditions
- Perioperative Complication
- Being tested
- SGLT2 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Also called Dapagliflozin and Empagliflozin
Dapagliflozin 10 mg or Empagliflozin 25mg
| Study group | Role | What they receive |
|---|---|---|
| SGLT2 group | First group will receive SGLT2 (Dapaglifozin or Empagliflozin) inhibitors one month before surgery and three months after surgery. Receives: Drug: SGLT2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of cardiac function by speckle tracing between patients who will receive SGLT2 and patients who not.
We will measure cardiac function using speckle tracing method one month before cardiac surgery and three months after surgery
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nader Nabil, Assiut University
- Investigators
- Salma M Taha, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326528
- Sponsor's protocol ID
- SGLT2 inhibitors
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Braunwald E. The war against heart failure: the Lancet lecture. Lancet. 2015 Feb 28;385(9970):812-24. doi: 10.1016/S0140-6736(14)61889-4. Epub 2014 Nov 16.
PubMed 25467564Verma S, McMurray JJV. SGLT2 inhibitors and mechanisms of cardiovascular benefit: a state-of-the-art review. Diabetologia. 2018 Oct;61(10):2108-2117. doi: 10.1007/s00125-018-4670-7. Epub 2018 Aug 22.
PubMed 30132036Staels B. Cardiovascular Protection by Sodium Glucose Cotransporter 2 Inhibitors: Potential Mechanisms. Am J Cardiol. 2017 Jul 1;120(1S):S28-S36. doi: 10.1016/j.amjcard.2017.05.013. Epub 2017 May 30.
PubMed 28606341Butler J, Handelsman Y, Bakris G, Verma S. Use of sodium-glucose co-transporter-2 inhibitors in patients with and without type 2 diabetes: implications for incident and prevalent heart failure. Eur J Heart Fail. 2020 Apr;22(4):604-617. doi: 10.1002/ejhf.1708. Epub 2020 Jan 11.
PubMed 31926059Filippatos TD, Liontos A, Papakitsou I, Elisaf MS. SGLT2 inhibitors and cardioprotection: a matter of debate and multiple hypotheses. Postgrad Med. 2019 Mar;131(2):82-88. doi: 10.1080/00325481.2019.1581971.
PubMed 30757937
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcome of SGLT2 Inhibitors on Patients Who Undergo Cardiac Surgery in Perioperative Period
- ClinicalTrials.gov ID
- NCT06326528
- Acronym / sponsor ID
- SGLT2 inhibitors
- Conditions
- Perioperative Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 22 Mar 2024 (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.
The expanded use of SGLT2 inhibitors motivates us to assess the role of SGLT2 inhibitors in perioperative period on patients who will undergo cardiac surgery in Assiut University.
Detailed description
With over 50 million cases of heart failure worldwide, heart failure is one of the most serious health issues facing humanity. Heart failure patients still have an extremely poor prognosis and quality of life, even with advancements in heart failure treatment. It continues to be the most common cause of hospitalization in elderly.
A substantial number of theories have been proposed to explain the beneficial effects of SGLT2 inhibitors. These include blood pressure lowering, increasing diuresis/natriuresis, improving cardiac energy metabolism, preventing inflammation, weight loss, improving glucose control, inhibiting the sympathetic nervous system, preventing adverse cardiac remodeling, preventing ischemia/reperfusion injury, inhibiting the cardiac Na/H exchanger inhibiting SGLT1, reducing hyperuricemia, increasing autophagy and lysosomal degradation, decreasing epicardial fat mass, increasing erythropoietin (EPO) levels, increasing circulating provascular progenitor cells, decreasing oxidative stress; and improving vascular function.
In addition to lowering blood sugar, several large trials also have demonstrated cardiovascular and renal benefits in patients with T2DM. Surprisingly, recent data also suggest that SGLT-2 inhibitors may improve cardiovascular and renal outcomes in patients without diabetes, leading to expanded indications for their use.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGLT2 group | – | Drug: SGLT2 inhibitorFirst group will receive SGLT2 (Dapaglifozin or Empagliflozin) inhibitors one month before surgery and three months after surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cardiac patients prepared for cardiac surgery
Key inclusion criteria (1 listed)
- 1. All subjects with coronary artery disease or valvular heart disease referred to cardiac surgery
Key exclusion criteria (6 listed)
- Congenital heart disease.
- Cardiomyopathy (EF>40%).
- Sever renal impairment (eGFR>30).
- COPD.
- Marked obesity (BMI<35).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 inhibitorAlso: Dapagliflozin and EmpagliflozinDapagliflozin 10 mg or Empagliflozin 25mg | Drug | SGLT2 group |
Primary outcome
Difference of cardiac function by speckle tracing between patients who will receive SGLT2 and patients who not.
Time frame: six months
We will measure cardiac function using speckle tracing method one month before cardiac surgery and three months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Background: PubMed 25467564Braunwald E. The war against heart failure: the Lancet lecture. Lancet. 2015 Feb 28;385(9970):812-24. doi: 10.1016/S0140-6736(14)61889-4. Epub 2014 Nov 16.
- Background: PubMed 30132036Verma S, McMurray JJV. SGLT2 inhibitors and mechanisms of cardiovascular benefit: a state-of-the-art review. Diabetologia. 2018 Oct;61(10):2108-2117. doi: 10.1007/s00125-018-4670-7. Epub 2018 Aug 22.
- Background: PubMed 28606341Staels B. Cardiovascular Protection by Sodium Glucose Cotransporter 2 Inhibitors: Potential Mechanisms. Am J Cardiol. 2017 Jul 1;120(1S):S28-S36. doi: 10.1016/j.amjcard.2017.05.013. Epub 2017 May 30.
- Background: PubMed 31926059Butler J, Handelsman Y, Bakris G, Verma S. Use of sodium-glucose co-transporter-2 inhibitors in patients with and without type 2 diabetes: implications for incident and prevalent heart failure. Eur J Heart Fail. 2020 Apr;22(4):604-617. doi: 10.1002/ejhf.1708. Epub 2020 Jan 11.
- Background: PubMed 30757937Filippatos TD, Liontos A, Papakitsou I, Elisaf MS. SGLT2 inhibitors and cardioprotection: a matter of debate and multiple hypotheses. Postgrad Med. 2019 Mar;131(2):82-88. doi: 10.1080/00325481.2019.1581971.
- Individual participant dataSharing planned: Undecided
Related trials for Perioperative Complication
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Active, not recruiting
Prehabilitation in Pancreatic Surgery
Pancreatic Cancer, Periampullary Cancer
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
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. This study is not recruiting at the moment.
Salma M Taha, MD principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Complication, run by Assiut University.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nader N Fawzy, Master (01200394430 ext. 020, nader.nabilfawzy87@gahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of cardiac function by speckle tracing between patients who will receive SGLT2 and patients who not. (time frame: six months). 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 NCT06326528, which also lists 5 linked publications.
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 22 Mar 2024.