Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ochsner Health System
With
Gilead Sciences
The outcome of liver transplantation (LT) in the presence of moderate to severe POPH is significantly poor with a 50% reported mortality rate in LT recipients having a mean pulmonary artery pressure (mPAP) \>35 mmHg and 100% when the mPAP is greater than 50 mmHg; therefore, making moderate to severe POPH a contraindication to liver transplants. Those recipients with significant pulmonary artery pressure (PAP) may be denied the opportunity for transplant unless the mPAP is brought below 35 mmHg with medical treatment. This study will test the efficacy \& safety of the combination of using ambrisentan and tadalfil in reducing the Pulmonary Arterial Pressure to below 35 mmHg in patients with moderate to severe POPH as a means to candidacy for liver transplantation.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Child-Pugh Class Class A \& B Cirrhosis
mPAP ≥35mmHg
Pulmonary Capillary Wedge Pressure (PWCP) \<15mmHg on Right Heart Catheterization's (RHCs)
mPAP \> 50mmHg will be considered eligible unless they are World Health Organization (WHO) Functional Class IV
You may not be if
End stage renal disease on hemodialysis (ESRD on HD)
Renal dysfunction and GFR \< 30
AST, ALT \> 5 times the upper limit of normal
Total bilirubin ≥ 6.0
INR \> 2
* Initially, Child-Pugh Class C patients will be excluded; however, after the first 5 patients are included, if there is no signal of worsening liver function, the protocol may be amended to include patients with Class C cirrhosis.
