Chronic Hepatitis c Clinical Trial
Official title:
Pulmonary Arterial Hypertension in Patients With Direct-Acting Antiviral Medications for Hepatitis C Virus Infection - a Prospective Observational Cohort Study
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.
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