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

Pulmonary Arterial Hypertension Clinical Trial

— EVA3D  

Official title:

3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH (EVA 3D Pilot Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02207868
• Other study ID #: EVA 3D
• Status: Recruiting
• Start date: June 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• 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 (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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

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	Change of the left ventricular longitudinal strain	echocardiography	day 90 (+/- 7 days)
Secondary	wall thickness	echocardiography	90 days (+/- 7 days)
Secondary	left ventricular ejection fracture	echocardiography	90 days (+/- 7 Days)
Secondary	left ventricular stroke volume	echocardiography	90 days (+/- 7 days)
Secondary	Tricuspid Annular Plane Systolic Excursion (TAPSE)	echocardiography	90 days (+/- 7 days)
Secondary	right ventricular fractional area change	echocardiography	90 (+/- 7 days)