A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
The Study Hypothesis:
Aggressive, upfront, dual therapy for treatment-naïve NYHA I/II/III PAH is superior to a
traditional "step-up" approach.
The study will evaluate:
1. Impact of dual, upfront, therapy on cardiovascular parameters in PAH as gauged by
cardiac magnetic resonance imaging (cMRI) at 24 weeks and event free survival at outcome
at 48 weeks.
2. Value of novel biomarkers (NT-pro BNP, Mts1/S100A4, and insulin resistance) and
cutting-edge imaging technologies (cardiac MRI) as newer endpoints for clinical trials
in PAH.
3. Utility of longer clinical trial design with the use of combined clinical events as time
to clinical worsening surrogate