A Phase 4 interventional study of Ambrisentan Pill and Tadalafil Pill in Portopulmonary Hypertension, Pulmonary Hypertension and Cirrhosis, Liver, sponsored by Ochsner Health System. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-07.
Sponsored by Ochsner Health System · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of the combination of ambrisentan and tadalafil in reducing mPAP to below 35mmHg in patients with moderate to severe Portopulmonary Hypertension (POPH) as a means to candidacy for liver transplantation.
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.
Exclusion Criteria:
INR > 2
Qualifying participants will begin combination therapy with ambrisentan pill 5 mg daily and tadalafil pill 20 mg. After one week of therapy, patients will increase tadalafil pill to 40 mg daily and continue ambrisentan pill 5 mg daily. On day 15, patients will increase ambrisentan pill to 10 mg daily and continue at 40 mg of tadalafil pill daily.
Drug: Ambrisentan Pill · Drug: Tadalafil Pill
Will be administered as stated in Arm/Group Descriptions
Also known as: Letairis
Will be administered as stated in Arm/Group Descriptions
Also known as: Adcirca
Reduction in mPAP to 35mmHg
A Right Heart Catheterization will be performed in order to see if there's a reduction in mPAP to less than 35mmHg from baseline
Time frame: 2 months post initiation of therapy
Blood Pressure
Systemic Blood pressure
Time frame: 2 months post therapy
mPAP Reduction
Percent reduction in mPAP will be assessed and measured from baseline via RHC
Time frame: 2 months post initiation of therapy
Post-Transplant Survival Outcome: Alive or Dead at 30 days
Post-transplant survival comparing subjects with or without history of POPH
Time frame: Post-op Day 1 and 30
Kidney function evaluation through measurement of Creatinine levels (mg/dL)
Comprehensive metabolic panel will be completed at 2 months post therapy to assess kidney function
Time frame: baseline, 1 month, 2 month, 3 month, 6 month, 9 month, 12 months/end of treatment, 1 month post transplant
Liver Function test measured by AST (iu/L)
AST will be done to monitor and measure the degree of cirrhosis on the liver as well as the overall function of the liver
Time frame: baseline, 1 month, 2 month, 3 month, 6 month, 9 month, 12 months/end of treatment, 1 month post transplant
Liver Function test measured by ALT (iu/L)
ALT test will be done to monitor and measure the degree of cirrhosis on the liver as well as the overall function of the liver
Time frame: baseline, 1 month, 2 month, 3 month, 6 month, 9 month, 12 months/end of treatment, 1 month post transplant
Liver Function test measured by Bilirubin (mg/dL)
Bilirubin test will be done to monitor and measure the degree of cirrhosis on the liver as well as the overall function of the liver
Time frame: baseline, 1 month, 2 month, 3 month, 6 month, 9 month, 12 months/end of treatment, 1 month post transplant
Liver Function test measured by INR
INR test will be done to monitor and measure the degree of cirrhosis on the liver as well as the overall function of the liver
Time frame: baseline, 1 month, 2 month, 3 month, 6 month, 9 month, 12 months/end of treatment, 1 month post transplant
Right Ventricular (RV) Size in centimeters
To measure Right Ventricular Size in centimeters
Time frame: Baseline, 1-month, 6-month and 12 months post therapy, 1 month post transplant
Right Ventricular (RV) Qualitative Systolic Function: assessment that is categorized as normal, mildly depressed, moderately depressed or severely depressed
To measure Right Ventricular Qualitative Systolic Function assessment that is categorized as normal, mildly depressed, moderately depressed or severely depressed
Time frame: Baseline, 1-month, 6-month and 12 months post therapy, 1 month post transplant
Right Ventricular (RV) Function in centimeters
Tricuspid Annular Plane Systolic Excursion (TAPSE) measured in centimeters
Time frame: Baseline, 1-month, 6-month and 12 months post therapy and 1-month post transplant
Biomarker of Right ventricular failure
serum BNP
Time frame: baseline, 1 month, 2 month, 3 month, 6 month, 9 month, 12 months/end of treatment, 1 month post transplant
New York Heart Association Functional class
NYHA FC will be assessed by clinician at baseline and each subsequent visit
Time frame: baseline, 1 month, 2 month, 3 month, 6 month, 9 month, 12 months/end of treatment, 1 month post transplant
Change in 6 Minute Walk Distance
6 Minute walk will be performed at baseline and each study visit
Time frame: baseline, 1 month, 2 month, 3 month, 6 month, 9 month, 12 months/end of treatment, 1 month post transplant
Plan to share: No
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Ochsner Health System