SGLT2 Inhibitors and Perioperative Period

March 17, 2024 updated by: Nader Nabil, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cardiac patients prepared for cardiac surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SGLT2 group
First group will receive SGLT2 (Dapaglifozin or Empagliflozin) inhibitors one month before surgery and three months after surgery.
Drug: SGLT2 inhibitor
Dapagliflozin 10 mg or Empagliflozin 25mg
Other Names:
  • Dapagliflozin and Empagliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Salma M Taha, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

March 9, 2024

First Submitted That Met QC Criteria

March 17, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGLT2 INHIBITORS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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