Pulmonary Artery HypertensionNCT04094272
Pulmonary Arterial Hypertension in Patients With Direct-Acting Antiviral Medications for Hepatitis C Virus Infection
An observational study of Pulmonary Artery Hypertension and Chronic Hepatitis c, run by Kantonsspital Olten at 1 site in Switzerland.
Trial summary
The purpose of this study is the evaluation of PAH in patients, who are treated with DAA medication for HCV infection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Artery Hypertension, Chronic Hepatitis c
- What is being tested?
- transthoracic doppler-echocardiography (TTE)
- How many people
- 49 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2017to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Age 18-90 years
- Written informed consent
- New diagnosis of HCV, which requires the initiation of a DAA therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pulmonary Artery Hypertension, Chronic Hepatitis c
- Being tested
- transthoracic doppler-echocardiography (TTE)
- Medical subject headings
- Familial Primary Pulmonary Hypertension, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic hepatitis C participants | Participants with a newly started DAA medication for HCV infection were included in the study. Receives: Diagnostic Test: transthoracic doppler-echocardiography (TTE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pulmonary artery pressure
evaluation of pulmonary artery pressure change using transthoracic doppler-echocardiography (TTE
Measured: 2 years
Secondary outcomes (1)
Left and right ventricular structure and function
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.
Measured: 2. years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Jul 2017
- Primary completion1 May 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Artery HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Olten
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisha Arenja, Kantonsspital Olten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094272
- Sponsor's protocol ID
- PAH-HCV
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Arterial Hypertension in Patients With Direct-Acting Antiviral Medications for Hepatitis C Virus Infection - a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04094272
- Acronym / sponsor ID
- PAH-HCV
- Conditions
- Pulmonary Artery Hypertension, Chronic Hepatitis c
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Kantonsspital OltenUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic hepatitis C participants | – | Diagnostic Test: transthoracic doppler-echocardiography (TTE)Participants with a newly started DAA medication for HCV infection were included in the study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18-90 years
- Written informed consent
- New diagnosis of HCV, which requires the initiation of a DAA therapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transthoracic doppler-echocardiography (TTE)Transthoracic doppler-echocardiography (TTE) in patients with a new diagnosis of HCV before and after treatment with DAA medication. | Diagnostic test | Chronic hepatitis C participants |
Primary outcome
Assessment of pulmonary artery pressure
Time frame: 2 years
evaluation of pulmonary artery pressure change using transthoracic doppler-echocardiography (TTE
1 secondary outcome
Left and right ventricular structure and function
Time frame: 2. years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Artery Hypertension and Chronic Hepatitis c, run by Kantonsspital Olten at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pulmonary artery pressure (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.