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L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03402191
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Study Description
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Brief Summary:
This study compares L-arginine Versus Sildenafil as treatment for pulmonary hypertension in Children with Beta Thalassemia

Condition or disease Intervention/treatment Phase
Thalassemia Drug: L-arginine Drug: Sildenafil Phase 4

Detailed Description:
This study focuses on different lines of treatment for pulmonary hypertension in children with thalassemia as this study discusses the Effect of L-arginine Versus Sildenafil in Children with Beta Thalassemia Associated with Pulmonary Hypertension
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Clinical Study Evaluating the Effect of L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension
Actual Study Start Date : July 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: L-arginine
l-arginine for pulmonary hypertension in patients with thalassemia.
 Drug: L-arginine
l-arginine for thalassemia with pulmonary hypertension
Active Comparator: Sildenafil
Sildenafil for pulmonary hypertension in patients with thalassemia.
 Drug: Sildenafil
Sildenafil for thalassemia with pulmonary hypertension
Other Name: Viagra
No Intervention: Control
No pulmonary hypertension


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with improvement of pulmonary hypertension [ Time Frame: 6 months ]
    patients with improvement of pulmonary hypertension


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with thalassemia and pulmonary hypertension.

Exclusion Criteria:

  • Rheumatic heart diseases.
  • Other comorbid disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402191


Contacts
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Contact: Sherief Abd-Elsalam, MD 00201095159522 sheriefabdelsalam@yahoo.com

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Tanta, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794    Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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Principal Investigator: Sahar El-Haggar, Prof Tanta University - Faculty of Pharmacy
Study Director: Mohamed El-Shanshoury, Prof Tanta University Pediatrics Department
Study Chair: Osama Abd-rab El-Rasol, Prof Tanta University Pediatrics Department
Study Chair: Tarek Mostafa, Ass Prof Tanta University-Faculty of pharmacy
Study Chair: Eman El-Khateeb, Msc Tanta University-Faculty of pharmacy
More Information
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Responsible Party: Sherief Abd-Elsalam, PhDTropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT03402191    
Other Study ID Numbers: Prof Elshanshoury
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Thalassemia
beta-Thalassemia
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents