Pulmonary Hypertension (PHT)Study

• Research type

  Research Study

• Full title

  Pilot of oral Sildenafil for the treatment of Pulmonary Hypertension in Thalassaemia with comparison to controls.

• IRAS ID

  15764

• Contact name

  John B Porter

• Sponsor organisation

  University College London

• Eudract number

  2009-016096-29

• Clinicaltrials.gov Identifier

  NCT00872170

• Research summary

  The purpose of this pilot study is to evaluate the safety and efficacy of oral sildenafil therapy for the treatment of Pulmonary Hypertension (PHT) in patients with thalassaemia in preparation for development of future trials as warranted. Efficacy will be evaluated with respect to changes in exercise capacity, cardiopulmonary hemodynamics, pulmonary function and structure, and biomarkers of haemolysis, arginine-nitric oxide pathway dysregulation, hypercoagulability, inflammation, and cardiac load. Comparison of thalassaemia patients with and without PHT will permit characterization of PHT in thalassaemia.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  10/H0505/3

• Date of REC Opinion

  5 Mar 2010

• REC opinion

  Further Information Favourable Opinion