SGLT2 Inhibitors and Perioperative Period

NCT ID: NCT06326528

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-10-01

Brief Summary

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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

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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

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Perioperative Complication

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SGLT2 group

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

SGLT2 inhibitor

Intervention Type DRUG

Dapagliflozin 10 mg or Empagliflozin 25mg

Interventions

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SGLT2 inhibitor

Dapagliflozin 10 mg or Empagliflozin 25mg

Intervention Type DRUG

Other Intervention Names

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Dapagliflozin and Empagliflozin

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Nader Nabil

AssiutU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salma M Taha, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Nader N Fawzy, Master

Role: CONTACT

01200394430 ext. 020

References

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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.

Reference Type BACKGROUND
PMID: 25467564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30132036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28606341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31926059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30757937 (View on PubMed)

Other Identifiers

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SGLT2 inhibitors

Identifier Type: -

Identifier Source: org_study_id

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