Pulmonary Arterial HypertensionEVA3DNCT02207868
3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH
An observational study of Pulmonary Arterial Hypertension, run by Regina Steringer-Mascherbauer at 1 site in Austria.
Trial summary
The aim of the study is to document the left and right ventricular function in patients with sclerodermia associated pulmonal arterial hypertension via 3D echocardiography. The results of this study should help to generate hypothesis for further future studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- How many people
- 6 participants
- Where
- 1 siteAustria
- Study dates
- Jun 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: patients with pulmonary arterial hypertension associated with WHO group 1 who start with a parenteral prostanoidtherapy.
Who may be able to join
- age >17
- pulmonary arterial hypertension (PAH) associated with WHO group 1 who start a parenteral prostanoid-therapy
- written informed consent
- prostanoid naive
- no change of the PAH specific therapy within 3 weeks of the recruitment to the study
Who cannot join
- pregnancy and lactation period
- Women of child bearing 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 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: 3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH (EVA 3D Pilot Study)
The aim of the study is to document the left and right ventricular function in patients with sclerodermia associated pulmonal arterial hypertension via 3D echocardiography. The results of this study should help to generate hypothesis for further future studies.
The primary hypothesis is that the increased use of modern image guided methods could provide essential aspects for the follow up.
Read the detailed description
The 3D echocardiography could provide early and detailed information about the changes in the left and right ventricle.
The prediction of sclerodermia associated pulmonary arterial hypertension (PAH) is rather adverse, so it makes sense to evaluate relevant changes of the left-ventricular longitudinal strain soon to adapt the PAH specific therapy accordingly.
- Conditions
- 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 |
|---|---|---|
| no treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the left ventricular longitudinal strain
echocardiography
Measured: day 90 (+/- 7 days)
Secondary outcomes (5)
wall thickness
echocardiography
Measured: 90 days (+/- 7 days)
left ventricular ejection fracture
echocardiography
Measured: 90 days (+/- 7 Days)
left ventricular stroke volume
echocardiography
Measured: 90 days (+/- 7 days)
Tricuspid Annular Plane Systolic Excursion (TAPSE)
echocardiography
Measured: 90 days (+/- 7 days)
right ventricular fractional area change
echocardiography
Measured: 90 (+/- 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startJun 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 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
- 6 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
- NCT02207868
- Sponsor's protocol ID
- EVA 3D
- Acronym
- EVA3D
- Status last verified
- May 2018
- First submitted
- 21 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
- 3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH (EVA 3D Pilot Study)
- ClinicalTrials.gov ID
- NCT02207868
- Acronym / sponsor ID
- EVA3D / EVA 3D
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Regina Steringer-MascherbauerUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Aug 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 document the left and right ventricular function in patients with sclerodermia associated pulmonal arterial hypertension via 3D echocardiography. The results of this study should help to generate hypothesis for further future studies.
The primary hypothesis is that the increased use of modern image guided methods could provide essential aspects for the follow up.
Detailed description
The 3D echocardiography could provide early and detailed information about the changes in the left and right ventricle.
The prediction of sclerodermia associated pulmonary arterial hypertension (PAH) is rather adverse, so it makes sense to evaluate relevant changes of the left-ventricular longitudinal strain soon to adapt the PAH specific therapy accordingly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with pulmonary arterial hypertension associated with WHO group 1 who start with a parenteral prostanoidtherapy.
Key inclusion criteria (5 listed)
- age >17
- pulmonary arterial hypertension (PAH) associated with WHO group 1 who start a parenteral prostanoid-therapy
- written informed consent
- prostanoid naive
- no change of the PAH specific therapy within 3 weeks of the recruitment to the study
Key exclusion criteria (5 listed)
- pregnancy and lactation period
- Women of child bearing 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 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
Change of the left ventricular longitudinal strain
Time frame: day 90 (+/- 7 days)
echocardiography
5 secondary outcomes
wall thickness
Time frame: 90 days (+/- 7 days)
left ventricular ejection fracture
Time frame: 90 days (+/- 7 Days)
left ventricular stroke volume
Time frame: 90 days (+/- 7 days)
Tricuspid Annular Plane Systolic Excursion (TAPSE)
Time frame: 90 days (+/- 7 days)
right ventricular fractional area change
Time frame: 90 (+/- 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
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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.
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, 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?
Change of the left ventricular longitudinal strain (time frame: day 90 (+/- 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.