Atrial FibrillationNCT06251453
Impact of Sodium-glucose Cotransporter 2 Inhibitors on Post-operative Atrial Fibrillation in Cardiothoracic Surgery
An observational study of Atrial Fibrillation, run by Hamad Medical Corporation at 2 sites in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- SGLT2 inhibitor
- How many people
- 3,280 participants
- Where
- 2 sitesQatar
- Study dates
- 1 Oct 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older 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)
Who may be able to join
- 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.
Who cannot join
- Known AF on anticoagulation.
- Chronic kidney disease with CrCl < 25 mL/min.
Trial locations and contacts
2 sites in 1 country.
Qatar2 sites, 2 recruiting
- Recruiting
Alaa Rahal
Doha, DA, 3050
Ala Rahal, MSC pharm, 00974395897, ARahhal1@hamad.qa
Alaa Rahal, MSC pharm, 00974395897, ARahhal1@hamad.qa
- Recruiting
Hamad medical corporation
Doha, DA, 3050
Alaa Rahal, Msc Pharma, 66346543, ARahhal1@hamad.qa
About this study
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.
Read the 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).
- Conditions
- Atrial Fibrillation
- Being tested
- SGLT2 inhibitor
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Dapagliflozin Empagliflzoin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: SGLT2 inhibitor | |
| SGLT2 inhibitors non-users | Adults not receiving SGLT2 inhibitors undergoing cardiothoracic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-operative atrial fibrillation (POAF)
Confirmed AF after surgery, regardless of frequency, duration, or intervention used for termination
Measured: 1 month
Secondary outcomes (2)
Euglycemic diabetic ketoacidosis
Incidence of euglycemic diabetic ketoacidosis after surgery
Measured: 1 month
Urinary tract infection
Incidence of urinary tract infection after surgery
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Oct 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251453
- Sponsor's protocol ID
- MRC-01-23-470
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sodium-glucose Cotransporter 2 Inhibitors on Post-operative Atrial Fibrillation in Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT06251453
- Acronym / sponsor ID
- MRC-01-23-470
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,280 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2 inhibitors users | – | Drug: SGLT2 inhibitorAdults undergoing cardiothoracic surgery who had been using SGLT2 inhibitors for a minimum of 1 week before surgery, regardless of diabetes status |
| SGLT2 inhibitors non-users | – | –Adults not receiving SGLT2 inhibitors undergoing cardiothoracic surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Known AF on anticoagulation.
- Chronic kidney disease with CrCl < 25 mL/min.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 inhibitorDapagliflozin Empagliflzoin | Drug | SGLT2 inhibitors users |
Primary outcome
Incidence of post-operative atrial fibrillation (POAF)
Time frame: 1 month
Confirmed AF after surgery, regardless of frequency, duration, or intervention used for termination
2 secondary outcomes
Euglycemic diabetic ketoacidosis
Time frame: 1 month
Urinary tract infection
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Hamad Medical Corporation at 2 sites in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa Rahhal, Msc (55712353, ARahhal1@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-operative atrial fibrillation (POAF) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.