Sildenafil to Improve Exercise Capacity in People With Thalassemia and Pulmonary Hypertension

Phase 2/3 Completed 27 enrolled Carelon Research National Heart, Lung, and Blood Institute (NHLBI) · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Thalassemia is an inherited blood disorder that can result in mild to severe anemia. Many people with thalassemia also have pulmonary hypertension, which is high blood pressure in the arteries in the lungs. This study will evaluate the safety and effectiveness of the medication sildenafil at reducing blood pressure in the lungs of people with thalassemia and pulmonary hypertension.

Timeline

Start: 2009-03
Primary completion: 2010-06
Completion: 2010-11

Publications

Results Morris CR, Kim HY, Wood J, Porter JB, Klings ES, Trachtenberg FL, Sweeters N, Olivieri NF, Kwiatkowski JL, Virzi L, Singer ST, Taher A, Neufeld EJ, Thompson AA, Sachdev V, Larkin S, Suh JH, Kuypers FA, Vichinsky EP; Thalassemia Clinical Research Network. Sildenafil therapy in thalassemia patients with Doppler-defined risk of pulmonary hypertension. Haematologica. 2013 Sep;98(9):1359-67. doi: 10.3324/haematol.2012.082065. Epub 2013 Apr 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Sildenafil	Unknown	1 mg/kg	Oral
Comparator	Sildenafil	Unknown	100 mg	Oral

Sildenafil to Improve Exercise Capacity in People With Thalassemia and Pulmonary Hypertension

Summary

Timeline

Publications

Drugs

Indications