Pulmonary Arterial Hypertension in Patients With Direct-Acting Antiviral Medications for Hepatitis C Virus Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the evaluation of PAH in patients, who are treated with DAA medication for HCV infection.

Detailed Description
-----------------
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. Measurements and procedures: The patients will receive a TTE for the measurement of the pulmonary artery pressure before, during (8 weeks after starting the medication) and 8 weeks after completion of the HCV medication. The whole treatment period will take about 12 weeks. Study Product / Intervention: The study will use a TTE for measurement of pulmonary artery pressure. This non-invasive, fast investigation (total duration about 20 minutes) is used for years in Cardiology and does not constitute a specific study product. Number of Participants with Rationale:The study goal ist the înlusion of 50 participants with a newly started DAA medication for HCV infection. Due to the lack of data, a power calculation is not possible. However, if a higher number than 50 participants would be necessary to show a significant rise in pulmonary pressure, a clinical significance is not likely to be relevant. Study Duration: The study inclusion is planned for 2 year.

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

Conditions
-----------------
Pulmonary Artery Hypertension, Chronic Hepatitis c

Intervention / Treatment
-----------------
* Diagnostic Test: transthoracic doppler-echocardiography (TTE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-90 years Written informed consent New diagnosis of HCV, which requires the initiation of a DAA therapy Exclusion Criteria: Inability to provide informed consent Known diagnosis of pulmonary artery hypertension (PAH) Dyspnoe NYHA III-IV Mean pulmonary artery (PA) pressure (mPAP) of >25 mmHg in the first TTE before start of DAA medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic hepatitis C participants<br>Participants with a newly started DAA medication for HCV infection were included in the study. | Diagnostic Test: transthoracic doppler-echocardiography (TTE)<br>* Transthoracic doppler-echocardiography (TTE) in patients with a new diagnosis of HCV before and after treatment with DAA medication.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pulmonary artery pressure | evaluation of pulmonary artery pressure change using transthoracic doppler-echocardiography (TTE | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left and right ventricular structure and function | 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. | 2. years |