Impact of Sodium-glucose Cotransporter 2 Inhibitors on Po... | NCT06251453

Studies
Impact of Sodium-glucose Cotransporter 2 Inhibitors on Post-operative Atrial Fibrillation in Cardiothoracic Surgery

NCT06251453

Sponsor

Hamad Medical Corporation

Status

Unknown status

Last Update Posted

Feb 9, 2024Actual

Enrollment

3,280Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

SGLT2 inhibitor

Countries

Qatar

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Actual

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Jan 31, 2025Estimated

First Submitted Date

Sep 27, 2023

First Submission Date that Met QC Criteria

Feb 8, 2024

First Posted Date

Feb 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2024

Last Update Posted Date

Feb 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

SGLT2 inhibitors are oral anti-diabetic medications that were found to improve cardiorenal outcomes in patients with type 2 diabetes mellitus (DM), chronic heart failure with reduced and preserved ejection fraction, and chronic kidney disease. Recent evidence suggested that the use of SGLT2 inhibitors resulted in a significant reduction in atrial fibrillation (AF) over a mean follow-up duration of 2.6 years. Given the possible AF protective benefit with SGLT2 inhibitors use.

Detailed Description

we aim to conduct a retrospective cohort study to evaluate the impact of SGLT2 inhibitors use on post-operative AF (POAF) among patients undergoing cardiothoracic surgery, including coronary artery bypass grafting (CABG), valve replacement, and valve repair over a 6-year period (from 1/06/2017 to 1/07/2023). The follow-up period will be the post-operative hospital stay or 30-days, whichever is shorter, and the data will be obtained from the electronic medical records. The study outcomes will include effectiveness outcomes of incidence of POAF regardless of frequency, duration, or intervention used for termination, incidence of paroxysmal POAF, incidence of paroxysmal POAF requiring pharmacological cardioversion, incidence of hemodynamically unstable POAF requiring electrical cardioversion, incidence of persistent POAF (sustained beyond 7 days), incidence of POAF requiring anticoagulation, ischemic stroke, and safety outcomes of euglycemic diabetic ketoacidosis and urinary tract infections (UTI).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,280Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SGLT2 inhibitors users		Adults undergoing cardiothoracic surgery who had been using SGLT2 inhibitors for a minimum of 1 week before surgery, regardless of diabetes status	Drug: SGLT2 inhibitor
SGLT2 inhibitors non-users		Adults not receiving SGLT2 inhibitors undergoing cardiothoracic surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SGLT2 inhibitor	Drug	Dapagliflozin Empagliflzoin	SGLT2 inhibitors users

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of post-operative atrial fibrillation (POAF)	Confirmed AF after surgery, regardless of frequency, duration, or intervention used for termination	1 month

Secondary Outcomes

Measure	Description	Time Frame
Euglycemic diabetic ketoacidosis	Incidence of euglycemic diabetic ketoacidosis after surgery	1 month
Urinary tract infection	Incidence of urinary tract infection after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults > 18 years undergoing cardiothoracic surgery, including CABG, mechanical valve replacement, bioprosthetic valve replacement, or valve repair.
Use of SGLT2 inhibitors for a minimum of 1 week prior to surgery regardless of DM status.
Resumption of SGLT2 inhibitor after stepping down from the intensive care unit.

Exclusion Criteria:

Known AF on anticoagulation.
Chronic kidney disease with CrCl < 25 mL/min.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

The study will include 2 groups:

Group 1: Adults undergoing cardiothoracic surgery who had been using SGLT2 inhibitors for a minimum of 1 week prior to surgery regardless of DM status (SGLT2 inhibitor users)
Group 2: Adults not receiving SGLT2 inhibitors undergoing cardiothoracic surgery (SGLT2 inhibitor non-users)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alaa Rahhal, Msc	Contact	55712353		ARahhal1@hamad.qa

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alaa Rahal	Recruiting	Doha	DA	3050	Qatar

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077203	Sodium-Glucose Transporter 2 Inhibitors

Ancestor Terms

ID	Term
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D007004	Hypoglycemic Agents

Browse Leaves

Not provided

Browse Branches

Not provided