Pulmonary Arterial Hypertension in Patients With Direct-Acting Antiviral Medications for Hepatitis C Virus Infection - a Prospective Observational Cohort Study

Study category and Rationale: This study is without any use of medication or investigations products, therefore this is a category A clinical trail.

Background and Rationale: Pulmonary arterial hypertension (PAH) is a chronic and progressive disease leading to right heart failure and ultimately death in untreated patients. A variety of systemic illnesses have been associated with PAH. Hepatitis C virus (HCV) infection is not defined as a risk factor for PAH. However, compared to a control population higher pulmonary artery pressures are described in patients with HCV. Some case reports indicate association between HCV medication and PAH. Except of a few case reports, to date no clinical study about evidence of PAH in patients with direct-acting-antiviral (DAA) medication for HCV infection has been published.

Objective: The purpose of this study is the evaluation of PAH in patients, who are treated with DAA medication for HCV infection.

Outcomes: The primary outcome of this study is the evaluation of pulmonary artery pressure change using transthoracic doppler-echocardiography (TTE) in patients with a new diagnosis of HCV before and after treatment with DAA medication. The secondary outcomes are the change in left and right ventricular structure and function using TTE in patients with a new diagnosis of HCV before and after treatment with DAA medication.

Study design: A single center prospective, observational cohort study. Inclusion / Exclusion criteria: Inclusion criteria are evidence of HCV infection and age 18-90 years. Patients will be excluded from the study, if there is an inability to provide informed consent and if there are known for existing PAH.