Clinical trial NCT04094272: Pulmonary Arterial Hypertension in Patients With Direct-Acting Antiviral Medications for Hepatitis C Virus Infection
Official title: Pulmonary Arterial Hypertension in Patients With Direct-Acting Antiviral Medications for Hepatitis C Virus Infection - a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Artery Hypertension
Chronic Hepatitis c
Lead sponsor: Kantonsspital Olten
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who will assign or present with diagnosis of HCV to the infectologist at the Kantonsspital Olten, (community clinic) wasl asked to take part in the study.

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.

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

Primary outcomes:
measure: Assessment of pulmonary artery pressure
timeFrame: 2 years
Secondary outcomes:
measure: Left and right ventricular structure and function
timeFrame: 2. years
Other outcomes:
Locations:
city: Olten
country: Switzerland
facility: Kantonsspital Olten
Study officials:
References: