Imaging Control Study, 3D Echo, MR and RHC.
PARIS
Prostanoid Therapy in Severe Pulmonary Arterial Hypertension - Imaging Control Study, 3D Echo, MR and RHC.
1 other identifier
observational
12
1 country
1
Brief 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. The hypothesis is that the increased use of modern imaging guided tools is essential 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 Jul 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
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 22, 2014
CompletedFirst Posted
Study publicly available on registry
July 23, 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
5.4 years
July 22, 2014
May 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
right ventricular ejection fracture
right-sided heart catheterization
month 12 (+/- 7 days)
Secondary Outcomes (4)
right atrial pressure
12 month (+/- 7 days)
cardiac index (CI)/cardiac output (CO)
12 months (+/- 7 Days)
pulmonary vascular resistance
12 months (+/- 7 days)
mean pulmonary capillary wedge pressure
12 month (+/-7 days)
Study Arms (1)
3D echocardiography
Eligibility Criteria
pulmonary arterial hypertension WHO group I
You may qualify if:
- age \>17
- pulmonary arterial hypertension WHO group I who are going to start a therapy with prostanoid
- written informed consent
- Prostanoid naive
You may not qualify if:
- 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)
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 22, 2014
First Posted
July 23, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
May 23, 2018
Record last verified: 2018-05