Topics

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

2019-09-24 05:27:36 | BioPortfolio

Summary

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

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.

Study Design

Conditions

Pulmonary Artery Hypertension

Intervention

transthoracic doppler-echocardiography (TTE)

Location

Kantonsspital Olten
Olten
Switzerland
4600

Status

Completed

Source

Kantonsspital Olten

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-24T05:27:36-0400

Clinical Trials [4075 Associated Clinical Trials listed on BioPortfolio]

The Role of Echocardiographic Contrast (Optison) in Enhancing Tricuspid Regurgitation Spectral Doppler Signals

The investigators aim to correlate noninvasive pulmonary artery systolic pressure (PASP) measurements obtained with and without echocardiographic contrast (Optison) during transthoracic ec...

Non-Invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography

Non-invasive evaluation of patients with stable angina and unstable coronary syndromes with transthoracic Doppler echocardiography to evaluate presence of significant coronary stenoses. Bl...

Diagnosis and Characterization of Coronary Artery Stenosis by Doppler Ultrasound

The purpose of this study is to evaluate the feasibility of acquisition of coronary blood flow velocity signals over the whole length of the LAD with transthoracic pulsed Doppler, and to e...

Diagnosis of Pulmonary Embolism by Doppler Signals

The LDS may contain information of significant diagnostic and physiological value regarding the pulmonary parenchyma and vasculature, as well as the cardio- vascular system in general. In ...

The Effect of Age on Intranasal Dexmedetomidine Sedation for Pediatric Transthoracic Echocardiography: A Dose-response Study

Increasing evidences suggest that dexmedetomidine pharmacokinetic are different in children. The investigators performed a two-stage study to determine the ED50 and the ED95 of intranasal ...

PubMed Articles [6709 Associated PubMed Articles listed on BioPortfolio]

A Doppler Echocardiographic Pulmonary Flow Marker of Massive or Submassive Acute Pulmonary Embolus.

To date, echocardiography has not gained acceptance as an alternative imaging modality for the detection of massive pulmonary embolism (MPE) or submassive pulmonary embolism (SMPE). The objective of t...

Multimodal Noninvasive Prediction of Pulmonary Hypertension in IPF.

Pulmonary hypertension (PH) complicating idiopathic pulmonary fibrosis (IPF) is challenging to diagnose given inaccuracy of transthoracic echocardiogram (TTE) measurements. However, it has significant...

Unusual presentation of acute pulmonary hypertension in a patient with bilateral pneumonia and hypertrophic cardiomyopathy.

: The incidence of acute pulmonary hypertension (APH) in hospitalized patients with pneumonia is not known with certainty, although a mild and/or moderate pulmonary hypertension is often detected by t...

Absence of the fetal right pulmonary artery complicated with coarctation of the aorta: Prenatal and postnatal diagnosis.

Unilateral absence of the pulmonary artery (UAPA) is a rare congenital cardiovascular malformation that can present as an isolated lesion or may be associated with other congenital heart malformations...

Transthoracic M-mode echocardiographic assessment of pulmonary vein-to-pulmonary artery ratio in healthy horses.

Equine cardiovascular structures and function are routinely assessed by transthoracic echocardiography. Recently, investigators have described the echocardiographic visualization of equine pulmonary v...

Medical and Biotech [MESH] Definitions

Echocardiography applying the Doppler effect, with the superposition of flow information as colors on a gray scale in a real-time image.

Echocardiography applying the Doppler effect, with velocity detection combined with range discrimination. Short bursts of ultrasound are transmitted at regular intervals and the echoes are demodulated as they return.

Measurement of intracardiac blood flow using an M-mode and/or two-dimensional (2-D) echocardiogram while simultaneously recording the spectrum of the audible Doppler signal (e.g., velocity, direction, amplitude, intensity, timing) reflected from the moving column of red blood cells.

Ultrasonic recording of the size, motion, and composition of the heart and surrounding tissues. The standard approach is transthoracic.

Placement of a balloon-tipped catheter into the pulmonary artery through the antecubital, subclavian, and sometimes the femoral vein. It is used to measure pulmonary artery pressure and pulmonary artery wedge pressure which reflects left atrial pressure and left ventricular end-diastolic pressure. The catheter is threaded into the right atrium, the balloon is inflated and the catheter follows the blood flow through the tricuspid valve into the right ventricle and out into the pulmonary artery.

More From BioPortfolio on "Pulmonary Arterial Hypertension in Patients With Direct-Acting Antiviral Medications for Hepatitis C Virus Infection"

Quick Search

Relevant Topics

Pulmonary Hypertension
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of affected individuals. Symptoms can range from mild breathles...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...


Searches Linking to this Trial