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

NCT ID: NCT02207868

Last Updated: 2018-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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no treatment

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regina Steringer-Mascherbauer

OTHER

Sponsor Role lead

Responsible Party

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Regina Steringer-Mascherbauer

OA Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Regina Steringer-Mascherbauer, MD

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus der Elisabethinen Linz GmbH

Locations

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Krankenhaus der Elisabethinen Linz GmbH

Linz, Upper Austria, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Regina Steringer-Mascherbauer, MD

Role: CONTACT

0043/732/7676 ext. 4916

Andrea Ploechl

Role: CONTACT

0043/732/7676 ext. 4415

Facility Contacts

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Regina Steringer-Mascherbauer, MD

Role: primary

0043/732/7676 ext. 4916

Other Identifiers

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EVA 3D

Identifier Type: -

Identifier Source: org_study_id

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