3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH (EVA3D)

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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Arterial Hypertension

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 Type: Observational
• Enrollment (Anticipated): 6

Contacts and Locations

Study Locations

• Austria
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Recruiting
      • Krankenhaus der Elisabethinen Linz GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with pulmonary arterial hypertension associated with WHO group 1 who start with a parenteral prostanoidtherapy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
no treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Regina Steringer-Mascherbauer

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: August 1, 2014
• First Posted (Estimate): August 4, 2014

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension
• Other Study ID Numbers: EVA 3D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED