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

NCT03402191 — Phase 4, Unknown, 60 participants, Sherief Abd-Elsalam

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Comparative Clinical Study Evaluating the Effect of L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension

Registry	NCT03402191
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	60 (Estimated)
Sponsor	Sherief Abd-Elsalam (Other)
Conditions	Thalassemia
Interventions	L-arginine, Sildenafil (Drug)
Dates	start 2016-07-01, primary completion 2023-12-01 (estimated), completion 2023-12-01 (estimated), first posted 2018-01-18, last updated 2018-08-27
Locations	1 site in Egypt

-Summary

This study compares L-arginine Versus Sildenafil as treatment for pulmonary hypertension in Children with Beta Thalassemia

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+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

+Arms and interventions

Arm	Type	Interventions	Description
L-arginine	Active comparator	Drug: L-arginine	l-arginine for pulmonary hypertension in patients with thalassemia.
Sildenafil	Active comparator	Drug: Sildenafil	Sildenafil for pulmonary hypertension in patients with thalassemia.
Control	No intervention		No pulmonary hypertension

L-arginine (Drug): l-arginine for thalassemia with pulmonary hypertension
Sildenafil (Drug), also known as Viagra: Sildenafil for thalassemia with pulmonary hypertension

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 6 Years to 18 Years

Inclusion Criteria:

* Children with thalassemia and pulmonary hypertension.

Exclusion Criteria:

* Rheumatic heart diseases.
* Other comorbid disease

+Locations (1)

Facility	City	Country	Status
Sherief Abd-Elsalam	Tanta	Egypt	Recruiting

+Investigators

Sahar El-Haggar, Prof, Principal investigator, Tanta University - Faculty of Pharmacy
Mohamed El-Shanshoury, Prof, Study director, Tanta University Pediatrics Department
Osama Abd-rab El-Rasol, Prof, Study chair, Tanta University Pediatrics Department
Tarek Mostafa, Ass Prof, Study chair, Tanta University-Faculty of pharmacy
Eman El-Khateeb, Msc, Study chair, Tanta University-Faculty of pharmacy

My Notes

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