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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

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT05470998

First Posted

July 17, 2022

Last Updated

July 20, 2022

Sponsor

Tanta University

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

Studies a U.S. FDA-regulated Device Product

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

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

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

dalia_gomaa@pharm.tanta.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity

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