Pulmonary Arterial Hypertension WHO Group IPARISNCT02198456
Imaging Control Study, 3D Echo, MR and RHC.
An observational study of Pulmonary Arterial Hypertension WHO Group I, run by Regina Steringer-Mascherbauer at 1 site in Austria.
Trial summary
The aim of the study is to intensify the follow up of patients with pulmonary arterial hypertension via modern imaging guided methods in due consideration of the possibilities of three-dimensional echocardiography in order to optimize their specific therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension WHO Group I
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2014to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: pulmonary arterial hypertension WHO group I
Who may be able to join
- age >17
- pulmonary arterial hypertension WHO group I who are going to start a therapy with prostanoid
- written informed consent
- Prostanoid naive
- no change of the pulmonary arterial hypertension therapy within 3 weeks of inclusion into the study
Who cannot join
- pregnancy and lactation period
- Women of childbearing potential who do not use an effective and secure method for birth control
- severe chronic kidney insufficiency (glomerular filtration rate <30), which will remain for more than 3 months
- liver insufficiency Child C
- life expectancy shorter than the course of the study (for example because of a malignant disease)
Trial locations and contacts
1 site in 1 country.
Regina Steringer-Mascherbauer, MD contact
Austria1 site, 1 recruiting
- Recruiting
Krankenhaus der Elisabethinen Linz GmbH
Linz, Upper Austria, 4020
Regina Steringer-Mascherbauer, MD, 0043/732/7676 ext. 4916, regina.mascherbauer@elisabethinen.or.at
About this study
Official title: Prostanoid Therapy in Severe Pulmonary Arterial Hypertension - Imaging Control Study, 3D Echo, MR and RHC.
The aim of the study is to intensify the follow up of patients with pulmonary arterial hypertension via modern imaging guided methods in due consideration of the possibilities of three-dimensional echocardiography in order to optimize their specific therapy.
The hypothesis is that the increased use of modern imaging guided tools is essential for the follow up.
Read the detailed description
It is not possible to perform a magnetic resonance imaging in all patients and as a result echocardiography is not only done at screening but also during the follow up. The imaging technologies made a great progress in the last few years and enable a better assessment of the haemodynamic parameters in our days.
- Keywords
- pulmonary arterial hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 3D echocardiography | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
right ventricular ejection fracture
right-sided heart catheterization
Measured: month 12 (+/- 7 days)
Secondary outcomes (4)
right atrial pressure
right-sided heart catheterization
Measured: 12 month (+/- 7 days)
cardiac index (CI)/cardiac output (CO)
right-sided heart catheterization
Measured: 12 months (+/- 7 Days)
pulmonary vascular resistance
right-sided heart catheterization
Measured: 12 months (+/- 7 days)
mean pulmonary capillary wedge pressure
right-sided heart catheterization
Measured: 12 month (+/-7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension WHO Group IStudies 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Steringer-Mascherbauer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Regina Steringer-Mascherbauer, Elisabethinen Hospital
- Investigators
- Regina Steringer-Mascherbauer, MD, Principal investigator, Krankenhaus der Elisabethinen Linz GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198456
- Sponsor's protocol ID
- Protocol PARIS3D
- Acronym
- PARIS
- Status last verified
- May 2018
- First submitted
- 22 Jul 2014
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostanoid Therapy in Severe Pulmonary Arterial Hypertension - Imaging Control Study, 3D Echo, MR and RHC.
- ClinicalTrials.gov ID
- NCT02198456
- Acronym / sponsor ID
- PARIS / Protocol PARIS3D
- Keywords
- pulmonary arterial hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Regina Steringer-MascherbauerUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Jul 2014 (estimated)
- 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 aim of the study is to intensify the follow up of patients with pulmonary arterial hypertension via modern imaging guided methods in due consideration of the possibilities of three-dimensional echocardiography in order to optimize their specific therapy.
The hypothesis is that the increased use of modern imaging guided tools is essential for the follow up.
Detailed description
It is not possible to perform a magnetic resonance imaging in all patients and as a result echocardiography is not only done at screening but also during the follow up. The imaging technologies made a great progress in the last few years and enable a better assessment of the haemodynamic parameters in our days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D echocardiography | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pulmonary arterial hypertension WHO group I
Key inclusion criteria (5 listed)
- age >17
- pulmonary arterial hypertension WHO group I who are going to start a therapy with prostanoid
- written informed consent
- Prostanoid naive
- no change of the pulmonary arterial hypertension therapy within 3 weeks of inclusion into the study
Key exclusion criteria (5 listed)
- pregnancy and lactation period
- Women of childbearing potential who do not use an effective and secure method for birth control
- severe chronic kidney insufficiency (glomerular filtration rate <30), which will remain for more than 3 months
- liver insufficiency Child C
- life expectancy shorter than the course of the study (for example because of a malignant disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
right ventricular ejection fracture
Time frame: month 12 (+/- 7 days)
right-sided heart catheterization
4 secondary outcomes
right atrial pressure
Time frame: 12 month (+/- 7 days)
cardiac index (CI)/cardiac output (CO)
Time frame: 12 months (+/- 7 Days)
pulmonary vascular resistance
Time frame: 12 months (+/- 7 days)
mean pulmonary capillary wedge pressure
Time frame: 12 month (+/-7 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Arterial Hypertension WHO Group I
Not yet recruitingPhase 3
A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations
Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension (PAH)
RecruitingPhase 4
Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension (RECOMPENSE)
Pulmonary Arterial Hypertension PAH, Pulmonary Arterial Hypertension WHO Group I
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.
Regina Steringer-Mascherbauer, MD contact
Regina Steringer-Mascherbauer, MD principal investigator
Krankenhaus der Elisabethinen Linz GmbH
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 Arterial Hypertension WHO Group I, run by Regina Steringer-Mascherbauer at 1 site in Austria.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 May 2018. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Regina Steringer-Mascherbauer, MD (0043/732/7676 ext. 4916, regina.mascherbauer@elisabethinen.or.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
right ventricular ejection fracture (time frame: month 12 (+/- 7 days)). 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 May 2018.