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Empagliflozin effect on supraventricular arrhythmias in heart failure patients with implantable cardioverter-defibrillator

Protocol summary

Study aim
The effects of empagliflozin, an SGLT2 inhibitor, on supraventricular arrhythmias such as atrial fibrillation (AF) and atrial flutter (AFL) in heart failure patients who have an implantable cardioverter-defibrillator (ICD)
Design
Before and after clinical trial on 30 patients
Settings and conduct
The study group is outpatients who take the drug at home for 3 months. First, the patient's demographic information is received and recorded in the hospital clinic. Then, patients are referred to a reference laboratory for checking CBC, electrolyte, blood glucose, lipid, liver, kidney, and thyroid function profiles. If eligible for the study, they will be evaluated for the frequency of supraventricular arrhythmias recorded by the ICD during the past 3 months. Then, empagliflozin 10 mg/day will administrated for three months. After three months of intervention, patients are re-evaluated for the frequency of supraventricular arrhythmias, and risk factors for supraventricular arrhythmias. The results are compared with the data of the patients three months before the intervention.
Participants/Inclusion and exclusion criteria
Adult patients with functional class I to III heart failure who have had an ICD for at least 3 months before will be included in the study. Patients who have previously used or have contraindications to SGLT2 inhibitors will not be included in the study.
Intervention groups
Taking empagliflozin tablets, 10 mg/day in the morning, regardless of food, for three months
Main outcome variables
Frequency of the supraventricular arrhythmias, including atrial fibrillation (AF) and atrial flutter (AFL)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240116060704N1
Registration date: 2024-01-22, 1402/11/02
Registration timing: prospective

Last update: 2024-01-22, 1402/11/02
Update count: 0
Registration date
2024-01-22, 1402/11/02
Registrant information
Name
Mohammad Tayyebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2000
Email address
tayyebim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-04, 1402/11/15
Expected recruitment end date
2024-05-04, 1403/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Empagliflozin effect on supraventricular arrhythmias in heart failure patients with implantable cardioverter-defibrillator
Public title
Empagliflozin effect on supraventricular arrhythmias
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years Diagnosis of heart failure based on echocardiography Having an ICD for more than 3 months before starting participation in the study Obtaining the patient's informed consent
Exclusion criteria:
Using SGLT2 inhibitors before starting participation in the study New York Heart Association function class IV heart failure Renal dysfunction (eGFR < 20 mL/min/1.73 m2 ) or dialysis Hepatic dysfunction (AST or ALT > 3 times higher than upper limit of normal) Body mass index < 18.5 kg/m2 Pregnancy or lactation Patients with the following events within 3 months before the eligibility test: alteration of the anti-arrhythmic drug, catheter ablation for supraventricular arrhythmia, coronary revascularization, open-heart surgery, development of coronary artery disease, stroke or transient ischemic stroke, seizure, infection requiring hospitalization Other commodities, including various infections, major surgery, type 1 diabetes, pituitary or adrenal insufficiency, cancer Single chamber ICDs or ICDs unable to record atrial arrhythmias
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Baqiyatallah Hospital
Street address
13th floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran St., between South Flamek and Zarafshan, Quds town (west)
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2024-01-08, 1402/10/18
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.089

Health conditions studied

1

Description of health condition studied
Supraventricular arrhythmias
ICD-10 code
148
ICD-10 code description
Atrial fibrillation and flutter

Primary outcomes

1

Description
Frequency of the supraventricular arrhythmias (atrial fibrillation and flutter)
Timepoint
During the three months before the intervention and during the three months after the intervention
Method of measurement
ICD (implantable cardioverter-defibrillator) record

Secondary outcomes

1

Description
Fasting blood sugar
Timepoint
At baseline and three months after intervention
Method of measurement
Fasting blood sugar level in blood test

2

Description
Blood pressure
Timepoint
At baseline and three months after intervention
Method of measurement
Sphygmomanometer

3

Description
Total cholesterol
Timepoint
At baseline and three months after intervention
Method of measurement
Total cholesterol level in blood test

4

Description
Heart rate
Timepoint
At baseline and three months after intervention
Method of measurement
Pulse oximeter

5

Description
Oxygen saturation
Timepoint
At baseline and three months after intervention
Method of measurement
Pulse oximeter

6

Description
Hemoglobin A1c (HbA1c)
Timepoint
At baseline and three months after intervention
Method of measurement
Hemoglobin A1c percentage in blood test

7

Description
Low-density lipoprotein (LDL)
Timepoint
At baseline and three months after intervention
Method of measurement
Level of low-density lipoprotein in blood test

8

Description
High-density lipoprotein (HDL)
Timepoint
At baseline and three months after intervention
Method of measurement
Level of high-density lipoprotein in blood test

9

Description
Triglyceride
Timepoint
At baseline and three months after intervention
Method of measurement
Level of triglyceride in blood test

Intervention groups

1

Description
Intervention group: Taking empagliflozin tablets from Abidi Company, 10 mg/day in the morning, regardless of food for three months (30 patients)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Heart Clinic of Imam Reza Hospital
Full name of responsible person
Mohammad Tayyebi
Street address
Ibn Sina Street, Imam Reza Hospital Square, Imam Reza Educational Research and Treatment Center
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
Tayyebim@mums.ac.ir

2

Recruitment center
Name of recruitment center
Heart Clinic of Baqiyatallah Hospital
Full name of responsible person
Morteza Khodaparast
Street address
Sheikh Bahaei corner, Molasadra St., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
mortezakhodaparast1360@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hassan Abolghasemi
Street address
Sheikh Bahaei corner, Molasadra St., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8804 0060
Email
R.bmsu@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research and Technology, Ghoreshi building, next to Hoveyzeh Cinema, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Majid Shohrati
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Sheikh Bahaei corner, Molasadra St., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8804 0060
Email
shohratimajid@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Tayyebi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Azadi Square, the east door of the university campus
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3800 2000
Fax
Email
tayyebim@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Tayyebi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Azadi Square, the east door of the university campus
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3800 2000
Fax
Email
tayyebim@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
After publication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Mention the source
From where data/document is obtainable
Dr. Majid Shohrati Email: shohratimajid@yahoo.com Phone: 0098 21 88040060
What processes are involved for a request to access data/document
Reply to email within a maximum of one week
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