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

• Conditions: Pulmonary Arterial Hypertension WHO Group I

• Registration Number: NCT02198456
• Lead Sponsor: Regina Steringer-Mascherbauer

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.

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-23
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-22
• Last Update Posted: 2018-05-23
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
right ventricular ejection fracture	month 12 (+/- 7 days)	right-sided heart catheterization

Secondary Outcome Measures

Name	Time	Method
cardiac index (CI)/cardiac output (CO)	12 months (+/- 7 Days)	right-sided heart catheterization
pulmonary vascular resistance	12 months (+/- 7 days)	right-sided heart catheterization
right atrial pressure	12 month (+/- 7 days)	right-sided heart catheterization
mean pulmonary capillary wedge pressure	12 month (+/-7 days)	right-sided heart catheterization

Trial Locations

Locations (1)

Krankenhaus der Elisabethinen Linz GmbH; 🇦🇹 Linz, Upper Austria, Austria