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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02207868

Acronym

EVA3D

Enrollment

Registered

2014-08-04

Start date

2014-06-30

Completion date

2019-12-31

Last updated

2018-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change of the left ventricular longitudinal strain	day 90 (+/- 7 days)	echocardiography

Secondary

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

Countries

Austria

Contacts

Primary ContactRegina Steringer-Mascherbauer, MD

regina.mascherbauer@elisabethinen.or.at0043/732/7676

Backup ContactAndrea Ploechl

andrea.ploechl@elisabethinen.or.at0043/732/7676

Outcome results