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The investigation of the efficacy and safety of Empagliflozin in the treatment of heart failure in people who living with HIV/AIDS: Randomized, Clinical Trial study

Protocol summary

Study aim
Efficacy and safety of empagliflozin compared to standard treatment in heart failure with low output in people with HIV/AIDS: a randomized clinical trial study
Design
The study group is HIV-positive people who refer to behavioral clinics and clinics of Tehran and Iran University and Shahid Beheshti hospitals. The clinical trial includes the control group. Phase 3. 136 people are divided into two arms in the form of block randomization, with 68 people in each arm.
Settings and conduct
This study is conducted in HIV positive patients with heart failure with low output in order to investigate the effect of empagliflozin in the treatment of these patients. If they have evidence of EF loss, they will enter the study and perform tests, ECG and 6-min test. For blinding in this method, a number of boxes that are numbered in a random sequence are used. In these boxes, intervention (medicine) and sheets in which random allocation is recorded are used. In this method, sufficient sealing and waxing of the boxes is ensured, and the boxes have the same weight and shape.
Participants/Inclusion and exclusion criteria
Inclusion criteria: • Age over 18 yearsm,HIV positive,Heart failure with ejection fraction less than50%. Exit criteria: Having malignancy or opportunistic infection, Pregnancy, Renal failure and GFR<20, Occurrence of drug side effects
Intervention groups
In this study, HIV positive patients with cardiac output below 50% are selected and the control group is given the standard treatment of heart failure and the intervention group is given the same standard treatment and empagloflozin is added to evaluate its effects in HIV positive patients
Main outcome variables
The main outcome of this investigation is whether the empagliflozin drug is effective in improving the symptoms of HIV heart failure patients and what are its side effects in this group.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130719014054N2
Registration date: 2024-06-25, 1403/04/05
Registration timing: registered_while_recruiting

Last update: 2024-06-25, 1403/04/05
Update count: 0
Registration date
2024-06-25, 1403/04/05
Registrant information
Name
Ladan Abbasian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1598
Email address
la-abbasian@sina.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2026-04-09, 1405/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of the efficacy and safety of Empagliflozin in the treatment of heart failure in people who living with HIV/AIDS: Randomized, Clinical Trial study
Public title
Investigating the effect of empagliflozin in heart failure in HIV patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age >18YEARS HIV EF<50%
Exclusion criteria:
MALIGNANCY OR Opportunistic infection PREGNANCY CKD AND GFR<20
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, a number of boxes that are numbered based on a random sequence are used. In these boxes, intervention (medicine) and sheets in which random allocation is recorded are used. In this method, sufficient sealing and waxing of the boxes is ensured, and the boxes have the same weight and shape
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Ghods St
City
تهران
Province
Tehran
Postal code
1417614411
Approval date
2024-05-12, 1403/02/23
Ethics committee reference number
IR.TUMS.IKHC.REC.1403.050

Health conditions studied

1

Description of health condition studied
Heart failure with low output in HIV positive patient
ICD-10 code
150.9
ICD-10 code description
Heart failure, unspecified

Primary outcomes

1

Description
Change in the 6min walking test
Timepoint
The beginning of the study and six months later and the end of the study
Method of measurement
The patients walks in a 30-meter hall with maximum power and the time of the patient's shortness of breath is recorded, and the maximum walking time of the patient will be 6 minutes.

Secondary outcomes

1

Description
Improve cardiac output
Timepoint
Every 6 months
Method of measurement
Echocardiography

2

Description
Function class
Timepoint
Every 3months
Method of measurement
Examining the patient and asking about the degree of shortness of breath

3

Description
Lower limb edema
Timepoint
Every 3months
Method of measurement
Examination by a doctor

4

Description
Hospitalized cases
Timepoint
Every 3months
Method of measurement
Question from the patient

5

Description
Change PRO-BNP
Timepoint
EVERY 6 MONTHS
Method of measurement
LAB TEST

6

Description
Change in uric acid
Timepoint
Every 6months
Method of measurement
lab test

Intervention groups

1

Description
Intervention group: In HIV-positive patients with heart failure, empagliflozin 10 mg, made in Iran, is added to other treatments including diuretics, beta-blockers, angiotensin inhibitors, and mineralocorticoid antagonists, and the patients are evaluated for one yea
Category
Treatment - Drugs

2

Description
Control group: HIV-positive patients with heart failure who are treated with beta blockers; diuretics; Mineralocorticoid antagonists and angiotensin enzyme inhibitors made in Iran are placed and followed up for one year.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
HIV Clinic
Full name of responsible person
Ladan Abbasian
Street address
Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6119 0000
Email
la.abbasian@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali akbari Sari
Street address
Keshavarz Blvd, Ghods S
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 8163 3685
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
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
Tehran University of Medical Sciences
Full name of responsible person
Marjan Hemmatian
Position
Non-academic specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6119 0000
Email
hemmatianmarjan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ladan Abbasian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6119 0000
Email
la.abbasian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marjan Hemmatian
Position
Non-academic specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6119 0000
Email
hemmatianmarjan@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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