Assessment of effect of L-Carnitine supplement on subclinical LV systolic dysfunction detected by speckletracking echocardiography in patients with ESRD under hemodiylisis
Determination of effect of L-Carnitine supplement on subclinical LV systolic dysfunction detected by Speckle Tracking echocardiography in patients with ESRD under hemodiylisis
Design
In this study at first Hemodialysis pateint undergo speckle tracking echocardiogarphy and their LVEF data will record then they treat with L-Carnitine supplement for 3 months after each session of HD and then again undergo Speckle echo and data will record and analysis will be done.this study will done on 34 hemodylisis pateint and has no control groups
Settings and conduct
This study will execute in the Namazi hospital Echocardiography Lab and pateint will randomized slect from Namazi hospital hemodialysis ward
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1)Left ventricular ejection fraction more than or equal of 50 persent
2)3 times a weak routine and regular hemodialysis
3)Agreement to take part in the study
4)Hemodialysis patient with age more than 18 who start hemodialysis for more than 3 months
5)If the pateint have been used L-Carnetine supplement before the study,should stop using it for at least 1 weak for entrance to our study
Exclusion criteria:
1)Pateint who used medicine which make drug intractions with the supplement
2)Pateints who are pregnant or have Liver Failure , Thyroid dysfunction, Nephrotic syndrome,Cancers, Vasculitis or other inflamatory disease
3)Disagreement to take part in the study
Intervention groups
intervention fulfil in the hamodialysis patient.the randomiz selected pateint will undergo echocardiogarphy and then treat with L-Carnitin after each session of hemodialysis andafter three months echo will done for the result
Main outcome variables
Left venticular ejection fraction and longitudinal global strain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221128056646N1
Registration date:2022-12-18, 1401/09/27
Registration timing:prospective
Last update:2022-12-18, 1401/09/27
Update count:0
Registration date
2022-12-18, 1401/09/27
Registrant information
Name
Mina Keshtkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3629 0110
Email address
minakeshtkar_828@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-21, 1401/09/30
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effect of L-Carnitine supplement on subclinical LV systolic dysfunction detected by speckletracking echocardiography in patients with ESRD under hemodiylisis
Public title
Assessment of effect of L-Carnitine supplement on subclinical LV systolic dysfunction detected by speckletracking echocardiography in patients with ESRD under hemodiylisis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Left ventricular ejection fraction more than or equal of 50 persent
3 times a weak routine and regular hemodialysis
Agreement to take part in the study
Hemodialysis patient with age more than 18 who start hemodialysis for more than 3 months
If the pateint have been used L-Carnetine supplement before the study,should stop using it for at least 1 weak for entrance to our study
Exclusion criteria:
Pateint who used medicine which make drug intractions with the supplement
Pateints who are pregnant or have Liver Failure , Thyroid dysfunction, Nephrotic syndrome,Cancers, Vasculitis or other inflamatory disease
Disagreement to take part in the study
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
34
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
Ethics committee of Shiraz University of Medical Sciences
Street address
No 7,second floor,Daneshvaran st, Shahid Mokhtari st, Chamran Blvd,Shiraz
City
Shiraz
Province
Fars
Postal code
7194896847
Approval date
2022-09-20, 1401/06/29
Ethics committee reference number
IR.SUMS.MED.REC.1401.321
Health conditions studied
1
Description of health condition studied
Patients with ESRD under hemodiylisis
ICD-10 code
ICD-10 code description
speckle echo
Primary outcomes
1
Description
Ejection fraction is define with the ability of left venticle to pump blood in each haert beat and bring up with percent
Timepoint
Ejection fraction measure in the begining of study and the after 3months of recivining L-Carnitine supplements
Method of measurement
Speckle tracking echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: we do this study with L-Carnitine oral solution with dosage of 1000 mg right after each session of hemodialysis which prescribe for 3 months.the manufactor company is Bonyan Salamat Kasra
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Mina keshtkar
Street address
No 7,second floor,Daneshvaran st, Shahid Mokhtari st, Chamran Blvd,Shiraz
City
shiraz
Province
Fars
Postal code
7194896847
Phone
+98 71 3629 0110
Email
minakeshtkar_828@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Street address
Zand Blvd,Shiraz univecity of medical science
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mina Keshtkar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No 7,second floor,Daneshvaran st, Shahid Mokhtari st, Chamran Blvd,Shiraz