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

NCT04094272 | Completed

• 1 other identifier: PAH-HCV
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Artery Hypertension; Chronic Hepatitis c

Outcome Measures

Primary Outcomes (1)

• Assessment of pulmonary artery pressure

  evaluation of pulmonary artery pressure change using transthoracic doppler-echocardiography (TTE

  2 years

Secondary Outcomes (1)

• Left and right ventricular structure and function

  2. years

Study Arms (1)

Chronic hepatitis C participants

Participants with a newly started DAA medication for HCV infection were included in the study.

Diagnostic Test: transthoracic doppler-echocardiography (TTE)

Interventions

transthoracic doppler-echocardiography (TTE) DIAGNOSTIC_TEST

Transthoracic doppler-echocardiography (TTE) in patients with a new diagnosis of HCV before and after treatment with DAA medication.

Chronic hepatitis C participants

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: self-representation of gender identity
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18-90 years
• Written informed consent
• New diagnosis of HCV, which requires the initiation of a DAA therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Kantonsspital Olten: lead

Study Sites (1)

Kantonsspital Olten

Olten, 4600, Switzerland

Location

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension; Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiovascular Imaging

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 18, 2019
• Study Start: July 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)