3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH

• Conditions: Pulmonary Arterial Hypertension

• Registration Number: NCT02207868
• Lead Sponsor: Regina Steringer-Mascherbauer

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.

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-04
• 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: 6

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of the left ventricular longitudinal strain	day 90 (+/- 7 days)	echocardiography

Secondary Outcome Measures

Name	Time	Method
left ventricular stroke volume	90 days (+/- 7 days)	echocardiography
right ventricular fractional area change	90 (+/- 7 days)	echocardiography
wall thickness	90 days (+/- 7 days)	echocardiography
left ventricular ejection fracture	90 days (+/- 7 Days)	echocardiography
Tricuspid Annular Plane Systolic Excursion (TAPSE)	90 days (+/- 7 days)	echocardiography

Trial Locations

Locations (1)

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