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Completed

NCT Number: NCT05470998

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

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

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tanta university

Tanta, Other (Non U.s.), Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-arginine

Drug

L-Arginine 1000 mg free form, rapid release capsules

Primary outcomes

  1. change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography

    Time frame: 3 months

    patients will undergo Color Doppler Echocardiography to assess tricuspid regurgitant jet velocity (TRJV) at baseline and after 3 months

Secondary outcomes

  1. change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP)

    Time frame: 3 months

    Blood samples will be collected at baseline and after 3 months

  2. change in serum level of L-Arginine

    Time frame: 3 months

    Blood samples will be collected at baseline and after 3 months

  3. change in serum level of Asymmetric Dimethyl Arginine (ADMA)

    Time frame: 3 months

    Blood samples will be collected at baseline and after 3 months

  4. change in serum level of Nitric Oxide

    Time frame: 3 months

    Blood samples will be collected at baseline and after 3 months

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2022
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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