SGLT2 Inhibitors and Perioperative Period

Perioperative Complication Clinical Trial

Official title:

Short Term Outcome of SGLT2 Inhibitors on Patients Who Undergo Cardiac Surgery in Perioperative Period

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06326528
• Other study ID #: SGLT2 inhibitors
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: Nader N Fawzy, Master
• Phone: 01200394430
• Email: nader.nabilfawzy87[@]gahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. All subjects with coronary artery disease or valvular heart disease referred to cardiac surgery

Exclusion Criteria:

1. Congenital heart disease.

2. Cardiomyopathy (EF>40%).

3. Sever renal impairment (eGFR>30).

4. COPD.

5. Marked obesity (BMI<35).

6. Previous cardiac surgery.

Related Conditions & MeSH terms

• Perioperative Complication

Intervention

Drug:
• SGLT2 inhibitor
Dapagliflozin 10 mg or Empagliflozin 25mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

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. — View Citation

Butler 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. — View Citation

Filippatos 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. — View Citation

Staels 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. — View Citation

Verma 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	six months