Hypertension, Pulmonary Clinical Trial
Official title:
CombinatiON Up-FRON t Therapy for PAH - A Phase 4, Randomized, Multicenter Study of Inhaled Treprostinil in Treatment naïve Pulmonary Arterial Hypertension Patients Starting on Tadalafil
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
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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