Overall purpose:
Determination the effect of oral L-arginine on pulmonary hypertension in patients with thalassemia major
Specific purposes:
Determination and comparison of PAP levels before and after the intervention
Determination and comparison of systemic blood pressure before and after the intervention
Determination and comparison of right ventricular dysfunction before and after the intervention
Determination and comparison of TAPSE C before and after the intervention
Design
All 50 patients with thalassemia referred to the thalassemia clinic of Hajar hospital in Shahrekord will be included in the study if pulmonary hypertension and patient satisfaction are present.Due to the limitation of the sample size, this study was designed as a pre- and post-test. Due to the lack of control group, this study was not blinded.
Settings and conduct
Thalassemia Clinic of Hajar Hospital, Shahrekord
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Major or intermedia thalassemia with PAP> 30
Systemic blood pressure above 90/60
Not taking blood pressure lowering medications
No use of Sildenafil and Bosentan
Exclusion criteria:
Allergic reaction to L-arginine
Smoking
Systemic blood pressure drops to less than 90/60
Liver, kidney and thyroid diseases
Intervention groups
All 50 patients with thalassemia referred to the thalassemia clinic of Hajar hospital in Shahrekord will be included in the study if pulmonary hypertension and patient satisfaction are present.
Main outcome variables
If L-arginine decreases PAP in thalassemic patients, this supplement may be used daily to improve the patient's cardiorespiratory status.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191218045785N1
Registration date:2020-01-18, 1398/10/28
Registration timing:registered_while_recruiting
Last update:2020-01-18, 1398/10/28
Update count:0
Registration date
2020-01-18, 1398/10/28
Registrant information
Name
Lale Najar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
najarlale@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-13, 1398/02/23
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of oral L-arginine on pulmonary hypertension in patients with thalassemia major
Public title
Investigation of the effect of oral L-arginine on pulmonary hypertension in patients with thalassemia major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Major or intermedia thalassemia with PAP> 30
Systemic blood pressure over 60/90
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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 Shahrekord University of Medical Sciences
Street address
University of Medical Sciences headquarters , Kashani Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2019-05-12, 1398/02/22
Ethics committee reference number
IR.SKUMS.REC.1398.046
Health conditions studied
1
Description of health condition studied
Beta thalassemia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pulmonary arterial pressure
Timepoint
Baseline (before intervention) and 6 and 30 days after L-arginine administration
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Systemic blood pressure
Timepoint
Baseline (before intervention) and 6 and 30 days after L-arginine administration
Method of measurement
Blood pressure monitor
Intervention groups
1
Description
Intervention group: Fifty patients with thalassemia major or intermedia are selected based on inclusion criteria. Due to the limited sample size, this study was designed as a pre- and post-test. All patients were initially echocardiographically diagnosed for pulmonary hypertension and systemic blood pressure was recorded. Patients are then given oral L-arginine capsules of 50 mg / kg daily divided into 3 doses. Echocardiography and systemic blood pressure measurements are performed again on the first, sixth day, and at the end of the first month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Thalassemia Clinic of Hajar Hospital, Shahrekord
Full name of responsible person
Dr Kiavash Fekri
Street address
Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 0016
Email
k.fekri@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Shahrekord University of Medical Sciences
Street address
Headquarter of Shahrekord Medical University
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
info@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Lale Najar
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics , Hajar hospital , Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Fax
Email
najarlale@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Lale Najar
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics , Hajar hospital , Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Fax
Email
najarlale@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Lale Najar
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics , Hajar hospital , Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Fax
Email
najarlale@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