SGLT2 Inhibitors and Perioperative Period

Not yet recruiting

• Conditions: Perioperative Complication
• Interventions: Drug: SGLT2 inhibitor

• Registration Number: NCT06326528
• Lead Sponsor: Assiut University

Brief 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.

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 Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-09
• Study First Submitted QC: 2024-03-17
• Last Update Submitted: 2024-03-17
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Study Start: 2024-05-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SGLT2 group	SGLT2 inhibitor	First group will receive SGLT2 (Dapaglifozin or Empagliflozin) inhibitors one month before surgery and three months after surgery.

Primary Outcome Measures

Name	Time	Method
Difference of cardiac function by speckle tracing between patients who will receive SGLT2 and patients who not.	six months	We will measure cardiac function using speckle tracing method one month before cardiac surgery and three months after surgery