pulmonary arterial hypertension in patients with direct-acting antiviral medications for hepatitis c virus infection

Conditions: Pulmonary Artery Hypertension; Chronic Hepatitis c

Summary: the purpose of this study is the evaluation of pah in patients, who are treated with daa medication for hcv infection.

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.

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