SGLT2 Inhibitors and Perioperative Period

NCT06326528 | Not Yet Recruiting

• 1 other identifier: SGLT2 inhibitors
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Perioperative Complication

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

SGLT2 group

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

Drug: SGLT2 inhibitor

Interventions

SGLT2 inhibitor DRUG

Dapagliflozin 10 mg or Empagliflozin 25mg

Also known as: Dapagliflozin and Empagliflozin

SGLT2 group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiac patients prepared for cardiac surgery

You may qualify if:

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

You may not qualify if:

• Congenital heart disease.
• Cardiomyopathy (EF\>40%).
• Sever renal impairment (eGFR\>30).
• COPD.
• Marked obesity (BMI\<35).
• Previous cardiac surgery.

Sponsors & Collaborators

• Assiut University: lead

Related 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.

  PMID: 25467564 BACKGROUND

• 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.

  PMID: 30132036 BACKGROUND

• 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.

  PMID: 28606341 BACKGROUND

• 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.

  PMID: 31926059 BACKGROUND

• 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.

  PMID: 30757937 BACKGROUND

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors; dapagliflozin; empagliflozin

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Salma M Taha, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nader N Fawzy, Master

CONTACT

01200394430; nader.nabilfawzy87@gahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: AssiutU

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 22, 2024
• Study Start: May 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-03