L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity
Primary Purpose
Sickle Cell Disease
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
L-Arginine
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease
Eligibility Criteria
Inclusion Criteria:
- children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
- age 5-18 years
Exclusion Criteria:
- Another chronic hemolytic anemia.
- Patients with documented causes of pulmonary hypertension other than SCD.
- Allergy to L-arginine.
- Patients with Asthma.
- Hepatic dysfunction: serum Alanine Aminotransferase (ALT) > 3X upper value.
- Renal dysfunction: Creatinine level greater than or equal to 1.2 mg/dl.
Sites / Locations
- Tanta universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
control group
L-Arginine group
Arm Description
this group will include 25 patients who will receive their standard therapy for 3 months
this group will include 25 patients who will receive L-Arginine 0.1-0.2 g/kg/day and their standard therapy for 3 months
Outcomes
Primary Outcome Measures
change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography
patients will undergo Color Doppler Echocardiography to assess tricuspid regurgitant jet velocity (TRJV) at baseline and after 3 months
Secondary Outcome Measures
change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP)
Blood samples will be collected at baseline and after 3 months
change in serum level of L-Arginine
Blood samples will be collected at baseline and after 3 months
change in serum level of Asymmetric Dimethyl Arginine (ADMA)
Blood samples will be collected at baseline and after 3 months
change in serum level of Nitric Oxide
Blood samples will be collected at baseline and after 3 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05470998
Brief Title
L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity
Official Title
Clinical Study to Evaluate the Possible Efficacy and Safety of L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aims to investigate the possible efficacy and safety of L-Arginine in children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
this group will include 25 patients who will receive their standard therapy for 3 months
Arm Title
L-Arginine group
Arm Type
Active Comparator
Arm Description
this group will include 25 patients who will receive L-Arginine 0.1-0.2 g/kg/day and their standard therapy for 3 months
Intervention Type
Drug
Intervention Name(s)
L-Arginine
Intervention Description
L-Arginine 1000 mg free form, rapid release capsules
Primary Outcome Measure Information:
Title
change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography
Description
patients will undergo Color Doppler Echocardiography to assess tricuspid regurgitant jet velocity (TRJV) at baseline and after 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP)
Description
Blood samples will be collected at baseline and after 3 months
Time Frame
3 months
Title
change in serum level of L-Arginine
Description
Blood samples will be collected at baseline and after 3 months
Time Frame
3 months
Title
change in serum level of Asymmetric Dimethyl Arginine (ADMA)
Description
Blood samples will be collected at baseline and after 3 months
Time Frame
3 months
Title
change in serum level of Nitric Oxide
Description
Blood samples will be collected at baseline and after 3 months
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
age 5-18 years
Exclusion Criteria:
Another chronic hemolytic anemia.
Patients with documented causes of pulmonary hypertension other than SCD.
Allergy to L-arginine.
Patients with Asthma.
Hepatic dysfunction: serum Alanine Aminotransferase (ALT) > 3X upper value.
Renal dysfunction: Creatinine level greater than or equal to 1.2 mg/dl.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
dalia A gomaa
Phone
01063410525
Email
dalia_gomaa@pharm.tanta.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dalia A gomaa
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta university
City
Tanta
State/Province
Other (Non U.s.)
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dalia A gomaa
Phone
01063410525
Email
dalia_gomaa@pharm.tanta.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity
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