1. Comparison of left ventricular end systolic volume (LVESV) before and after intervention in Empagliflozin and placebo groups
2. Comparison of left ventricular end diastolic volume (LVESV) before and after intervention in Empagliflozin and placebo groups
3. Comparison of left ventricular ejection fraction (LVEF) before and after intervention in Empagliflozin and placebo groups
4. Comparison of LVGLS before and after intervention in Empagliflozin and placebo groups
5. Comparison of cardiovascular complications in diabetic and pre-diabetic patients in Empagliflozin and placebo groups
6. Comparison of changes in left ventricular volumes in diabetic and pre-diabetic patients in two groups
Design
A double-blinded randomized clinical trial with placebo group, phase 3 on 112 patients. Randomization is performed using the permuted block randomization.
Settings and conduct
Emam Khomeini and Golestan hospitals, Ahvaz
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients with type 2 diabetes mellitus (HbA1C≥ 6.5%) or pre-diabetes (HbA1c between 5.7% to 6.4%) and ischemic heart failure with reduced fractional ejection (LVEF ≤ 40%)
2. Age over 18 years
3. Functional NYHA Class II to IV
4. Patient consent to participate in the study
Exclusion criteria:
5. Type 1 diabetes
6. Severe liver failure
7. History of diabetic ketoacidosis
8. Presence of any malignancy and cancer
9. Lack of adherence to the treatment regimen
10. eGFR < 30ml/min/1.73m2
Intervention groups
In the first group, Empagliflozin 10 mg is given once a day and in the second group, placebo. Patients are treated for 36 weeks. During the study, patients in both groups also receive standard HFrEF treatments.
Main outcome variables
In case of drug effects on the improvement of ventricular volume, fractional ejection and survival of patients, it can lead to a reduction in cardiovascular complications.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211219053450N1
Registration date:2022-06-05, 1401/03/15
Registration timing:prospective
Last update:2022-06-05, 1401/03/15
Update count:0
Registration date
2022-06-05, 1401/03/15
Registrant information
Name
Omid Sherafat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 8037
Email address
omidsherafat70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-16, 1401/04/25
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Empagliflozin on left ventricular volumes in type 2 diabetes or prediabetes patients with heart failure with reduced ejection fraction
Public title
Effect of Empagliflozin on left ventricular volumes in type 2 diabetes or prediabetes patients with heart failure with reduced ejection fraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes mellitus (HbA1C≥ 6.5%) or pre-diabetes (HbA1c between 5.7% to 6.4%) and ischemic heart failure with reduced fractional ejection (LVEF ≤ 40%)
over 18 years old
Functional NYHA Class II to IV
Patient consent for participation in research
Exclusion criteria:
Type 1 diabetes; Severe liver failure; eGFR <mL / min / 1.73m2 30;
History of diabetic ketoacidosis;
Existence of any malignancy and cancer;
Lack of adherence to the treatment regimen.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups of drugs and placebo. In this study, we will use the restricted randomization method of block randomization. The size of all the blocks is the same in both the drug and placebo groups, and we will have 4 blocks in this 2-group experiment. Randomization tool also uses random number tables.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is done in such a way that the person who randomizes and assigns people to groups has no information about the patients' condition and the study process. The patient and the person reviewing the results also did not know what group the people were in, and the study was conducted in a two-way blind.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Golestan Hospital, Ahvaz
Street address
Golestan street, Golestan hospital,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2021-11-30, 1400/09/09
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.134
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
left ventricular volumes
Timepoint
before and 6 months after intervention
Method of measurement
Echocardiographic parameters
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Impagliflozin drug at a dose of 10 mg is administered once a day for 36 weeks.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group receive placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini hospital, Ahvaz
Full name of responsible person
Omid Sherafat
Street address
Emam Khomeini hospital, Azadegan street, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 8037
Email
omidsherafat70@gmail.com
2
Recruitment center
Name of recruitment center
Golestan hospital, Ahvaz
Full name of responsible person
Omid Sherafat
Street address
Farvardin Ave, Golestan hospital, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3320 4501
Email
omidsherafat70@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?