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

Sponsor

Sherief Abd-Elsalam (Other)

Overall Status

Recruiting

CT.gov ID

NCT03402191

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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 Names: Viagra
No Intervention: Control No pulmonary hypertension

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 Names:

Viagra

No Intervention: Control

No pulmonary hypertension

Outcome Measures

Primary Outcome Measures

Number of patients with improvement of pulmonary hypertension [6 months]
patients with improvement of pulmonary hypertension

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children with thalassemia and pulmonary hypertension.

Exclusion Criteria:

Rheumatic heart diseases.
Other comorbid disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sherief Abd-Elsalam	Tanta		Egypt

Sponsors and Collaborators

Sherief Abd-Elsalam

Investigators

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