Evaluation of the effect of empagliflozin on prevention of atrial fibrillation after coronary artery bypass grafting (CABG) or heart valve replacement: a triple-blind, randomized, placebo-controlled trial
prevention of atrial fibrillation after CABG or valve replacement surgery by adding empagliflozin to drug regimen
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
80 patients that refer to Imam Reza hospital for heart surgery and complete the inclusion criteria will be included in this triple-blind, randomized, placebo-controlled trial. All of them will be monitored for 72 hrs after surgery and if they show AF rhythm for at least 5 minutes and confirmed by ICU physician, this will be considered as final outcome.
Participants/Inclusion and exclusion criteria
Previous use of empagliflozin or other SGLT2 inhibitor drugs
•sever heart failure (Class IV NYHA )
• Kidney dysfunction (GFR < 30 ml/min/1.73m2)
• Liver dysfunction (LFT > 3ULN)
• Very thin people (BMI ≤ 18.5 kg/m2)
• Pregnancy
• Having a pacemaker
• Having AF rhythm at first
• History of any heart surgery
Intervention groups
intervention group includes patients taking 10 mg empagliflozin tablets once daily from three days before to three days after surgery. control group includes patients taking placebo tablets two times a day from three days before to three days after surgery.
Main outcome variables
Incidence of AF; hospital stay lenght; High-sensitivity C-reactive protein (hs-CRP) concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120520009801N9
Registration date:2022-12-07, 1401/09/16
Registration timing:prospective
Last update:2022-12-07, 1401/09/16
Update count:0
Registration date
2022-12-07, 1401/09/16
Registrant information
Name
Amir Hooshang Mohammadpour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
mohamadpoorah@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of empagliflozin on prevention of atrial fibrillation after coronary artery bypass grafting (CABG) or heart valve replacement: a triple-blind, randomized, placebo-controlled trial
Public title
Evaluation of the effect of empagliflozin on prevention of atrial fibrillation after heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for heart surgery including CABG or valve replacement
70 yr > age > 18 yr
Taking ACEIs/ARBs, beta-blockers, statins and aspirin for CABG patients
Exclusion criteria:
History of taking empagliflozin drug before surgery
Severe heart failure (NYHA Class IV)
Renal failure (30 ≥ GFR)
Hepatic failure (hepatic enzymes > 3 times of upper normal limit )
pregnancy
Have pacemaker
Have AF rhythm
History of heart surgery
Very thin people (BMI ≤ 18.5 kg/m2)
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Alternate block randomization using www.randomization.com. Each block has 4 members and The aforementioned site selects twenty blocks out of quadruple blocks at random so that finally 160patients can be included in the study. The allocation concealment method is also the use of opaque sealed envelopes with random sequences obtained from the random allocation step.
Blinding (investigator's opinion)
Triple blinded
Blinding description
After taking the drug or placebo for three days by the patient who has been kept blind to the use of the drug or placebo, the patient is introduced to a nurse in the hospital and the medication is prescribed by the nurse (therapist). In addition, the evaluator (physician) who is different from the therapist (nurse) and does not know which drug the patient has received and is aware only of the assigned code, performs the relevant evaluations. After registration, the results are given to the person who performs the data analysis in the form of a code, and the data analysis is performed without the knowledge of the data analyzer, and all confidential information is recorded and stored without mentioning the patient's name.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ethic committee of Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91375-345
Approval date
2022-06-18, 1401/03/28
Ethics committee reference number
IR.MUMS.REC.1401.129
Health conditions studied
1
Description of health condition studied
Atrial fibrillation after heart surgery
ICD-10 code
148
ICD-10 code description
Paroxysmal atrial fibrillation
Primary outcomes
1
Description
The incidence of atrial fibrillation
Timepoint
Through 72 hrs after heart surgery
Method of measurement
Holter monitoring
Secondary outcomes
1
Description
C-Reactive Protein (CRP) blood concentration
Timepoint
Before surgery and 3 days after surgery
Method of measurement
Laboratory
2
Description
The incidence of ventricular and supra-ventricular arrhythmias
Timepoint
Through 72 hrs after heart surgery
Method of measurement
Holter monitoring
3
Description
Lenght of hospital stay
Timepoint
From heart surgery to discharge
Method of measurement
Counting of hospitalizations days
Intervention groups
1
Description
Intervention group: It includes patients who receive 10 mg empagliflozin tablets made by abidi under the brand name Gloripa once daily for three days before to three days after surgery. The drug is taken by the patient himself and at home during the three days before the surgery and during the three days after the surgery by the nurses working in the intensive care unit.
Category
Prevention
2
Description
Control group: It includes patients who receive a placebo once daily three days before to three days after surgery, which has been prepared in the Pharmaceutics Laboratory of Mashhad School of Pharmacy. The drug is taken by the patient himself and at home during the three days before the surgery and during the three days after the surgery by the nurses working in the intensive care unit.