3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH
EVA3D
1 other identifier
observational
6
1 country
1
Brief 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. The primary hypothesis is that the increased use of modern image guided methods could provide essential aspects for the follow up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 21, 2014
CompletedFirst Posted
Study publicly available on registry
August 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMay 23, 2018
May 1, 2018
5.5 years
July 21, 2014
May 22, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change of the left ventricular longitudinal strain
echocardiography
day 90 (+/- 7 days)
Secondary Outcomes (5)
wall thickness
90 days (+/- 7 days)
left ventricular ejection fracture
90 days (+/- 7 Days)
left ventricular stroke volume
90 days (+/- 7 days)
Tricuspid Annular Plane Systolic Excursion (TAPSE)
90 days (+/- 7 days)
right ventricular fractional area change
90 (+/- 7 days)
Study Arms (1)
no treatment
Eligibility Criteria
patients with pulmonary arterial hypertension associated with WHO group 1 who start with a parenteral prostanoidtherapy.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Krankenhaus der Elisabethinen Linz GmbH
Linz, Upper Austria, 4020, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Regina Steringer-Mascherbauer, MD
Krankenhaus der Elisabethinen Linz GmbH
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- OA Dr.
Study Record Dates
First Submitted
July 21, 2014
First Posted
August 4, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
May 23, 2018
Record last verified: 2018-05