NCT03309592

Efficacy and Safety of Combination Ambrisentan and Tadalafil in Patients With Portopulmonary Hypertension

Investigator Sponsored Research Proposal : Efficacy and Safety of Combination Ambrisentan and TadaLafil in PATiEnts With PortoPulmonary Hypertension (ESCALATE-PPH)

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ochsner Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Portopulmonary Hypertension
• Pulmonary Hypertension
• Cirrhosis, Liver

Interventions

Type	Name	Description
DRUG	Ambrisentan Pill	Will be administered as stated in Arm/Group Descriptions
DRUG	Tadalafil Pill	Will be administered as stated in Arm/Group Descriptions

Timeline

• Start date: 2017-10-12
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2017-10-13
• Last updated: 2018-12-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study