Determining the effectiveness of L-carnitine on heart failure patients
Design
This study is a double-blind randomized clinical trial with a control.
Settings and conduct
Heart failure patients will be identified after visiting the heart clinic of Modarres Hospital in the period of 2024-2025. The study is double blind.Patients, caregivers and doctors are not informed about the type of treatment. After the examination of the patients, the study will be explained to them and based on the randomization table, the supplement or placebo will be given to the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.heart failure and ejection fraction below 40%
2.18-70 years old
3.Consent to participate in the study
exclusion criteria:
1.inflammatory, infectious, autoimmune, malignant, kidney, liver or thyroid diseases
Intervention groups
Intervention group with supplements: heart failure patients treated with L-carnitine.
Control group:heart failure patients treated with placebo
Investigating the effectiveness of L-carnitine on heart failure patients
Public title
Investigating the effect of nutritional supplements in heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having heart failure and Ejection Fraction(EF) below 40
Exclusion criteria:
Having inflammatory, infectious, autoimmune and malignant , kidney, liver or thyroid diseases
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The website www.Randomization.com will be used for randomization (online randomization). For this purpose, a simple randomization model will be used. In this website, the number of intervention groups, which are two groups (L-carnitine and placebo), will be determined, and 50 blocks and two samples will be determined for each block. Then this website will provide us with a random table of numbers representing the patient's number and the desired intervention for him.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind and the patients and evaluators who check the effectiveness of the treatment will be unaware of the type of medicine received (supplement and placebo). Also, the study data analyst will only have the code of the treatment groups (1 and 2) and will not be able to distinguish the treatment groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Ethics Committee of Shahid Beheshti University of Medical Sciences Ethics Committee of Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Arabi St., Student Blvd., Velenjak st., Tehran.
Before the start of the intervention and 2 months after the start of L-carnitine supplementation or placebo
Method of measurement
Brief fatigue inventory (BFI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 250 mg L-carnitine daily for two months
Category
Treatment - Drugs
2
Description
Control group: Placebo daily for two months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Sepideh Jafari Naeini
Street address
Shahid Modares Hospital, End of Saadat Abad Blvd.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 912 216 8955
Email
sdnaeini@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sepideh Jafari Naeini
Street address
Shahid beheshti University of medical sciences Research Vice-Chancellor, Shahid Beheshti University of Medical Sciences, Arabi St., Daneshjoo Blvd., Volenjak St., Tehran.
City
Tehran
Province
Tehran
Postal code
199852468
Phone
+98 21 2387 1524
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sepideh Jafari Naeini
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shahid Modarres Hospital, Saadatabad Blvd.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Email
sdnaeini@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sepideh Jafari Naeini
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shahid Modarres Hospital, Saadatabad Blvd.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Email
sdnaeini@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sepideh Jafari Naeini
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shahid Modarres Hospital, Saadatabad Blvd.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Email
sdnaeini@yahoo.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