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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


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Study Type
Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

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Trial ID:
NCT02207868

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Regina Steringer-Mascherbauer

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Regina Steringer-Mascherbauer, MD
Principal Investigator Affiliation Krankenhaus der Elisabethinen Linz GmbH

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries Austria

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Pulmonary Arterial Hypertension
Additional Details

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.

Contact a Trial Team

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International Sites

Krankenhaus der Elisabethinen Linz GmbH, Linz, Upper Austria, Austria

Status

Recruiting

Address

Krankenhaus der Elisabethinen Linz GmbH

Linz, Upper Austria, 4020

Site Contact

Regina Steringer-Mascherbauer, MD

regina.mascherbauer@elisabethinen.or.at

0043/732/7676 #4916

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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