Ignite Creation Date:
2024-05-06 @ 1:41 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04094272
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2019-09-16
Brief Title:
Pulmonary Arterial Hypertension in Patients With Direct-Acting Antiviral Medications for Hepatitis C Virus Infection
Sponsor:
Kantonsspital Olten
Organization:
Kantonsspital Olten
Study Overview
Official Title:
Pulmonary Arterial Hypertension in Patients With Direct-Acting Antiviral Medications for Hepatitis C Virus Infection - a Prospective Observational Cohort Study
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 RationaleThe 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
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 RationaleThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None