Imaging Control Study, 3D Echo, MR and RHC.

Pulmonary Arterial Hypertension WHO Group I Clinical Trial

— PARIS  

Official title:

Prostanoid Therapy in Severe Pulmonary Arterial Hypertension - Imaging Control Study, 3D Echo, MR and RHC.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02198456
• Other study ID #: Protocol PARIS3D
• Status: Recruiting
• Start date: July 2014
• Est. completion date: December 2019

Study information

• Verified date: May 2018
• Source: Elisabethinen Hospital
• Contact: Regina Steringer-Mascherbauer, MD
• Phone: 0043/732/7676
• Email: regina.mascherbauer[@]elisabethinen.or.at
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

The hypothesis is that the increased use of modern imaging guided tools is essential for the follow up.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension WHO Group I

Locations

Country	Name	City	State
Austria	Krankenhaus der Elisabethinen Linz GmbH	Linz	Upper Austria

Sponsors (1)

Lead Sponsor	Collaborator
Regina Steringer-Mascherbauer

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	right ventricular ejection fracture	right-sided heart catheterization	month 12 (+/- 7 days)
Secondary	right atrial pressure	right-sided heart catheterization	12 month (+/- 7 days)
Secondary	cardiac index (CI)/cardiac output (CO)	right-sided heart catheterization	12 months (+/- 7 Days)
Secondary	pulmonary vascular resistance	right-sided heart catheterization	12 months (+/- 7 days)
Secondary	mean pulmonary capillary wedge pressure	right-sided heart catheterization	12 month (+/-7 days)