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
This is a 48 week interventional study evaluating the effect of Dual therapy ( Treprostinil inhalations and Tadalafil) versus Mono therapy (Tadalafil). The impact of the therapy on cardiovascular parameters in PAH measured at 24 weeks and event free survival outcome at 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
21
Treprostinil inhalation QID starting at 3 breaths per inhalation \& gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.
tadalafil 20mg QD PO increasing to 40mg QD as tolerated
Stanford University School of Medicine
Stanford, California, United States
Northwestern University
Chicago, Illinois, United States
Change in Right Ventricular Ejection Fraction
Effect of dual-upfront therapies versus mono-therapy on percent change of right ventricular function assesed by cardiac MRI (cMRI) at 24 weeks compared with the baseline.
Time frame: Basline and 24 weeks
6 Minute Walk Distance
Change in 6MWD during 24 week period compared between Tada and Tada+iTre.
Time frame: Baseline and 24 weeks
N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
Change from baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
Time frame: Baseline and 24 weeks
Change in NYHA/WHO Class
At 48 week,WHO/NYHA functional class was assessed for change in WHO/NYHA functional class.Change NYHA is measured as decrease or increase in NYHA class in the subjects compared with baseline. NYHA /WHO functional class is described below: NYHA functional class I:no symptoms and no limitation in ordinary physical activity NYHA functional class II:Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity NYHA functional class III:Marked limitation in activity due to symptoms, even during less-than-ordinary activity NYHA functional class IV:Severe limitations. Experiences symptoms even while at rest A higher functional class represent worse symptoms.
Time frame: Baseline and 48 week
B-type Natriuretic Peptide (BNP)
B-type Natriuretic peptide measures the percent change from baseline.
Time frame: Baseline and 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.