Imaging Control Study, 3D Echo, MR and RHC.

Overview

The aim of the study is to intensify the follow up of patients with pulmonary arterial hypertension via modern imaging guided methods in due consideration of the possibilities of three-dimensional echocardiography in order to optimize their specific therapy. The hypothesis is that the increased use of modern imaging guided tools is essential for the follow up.

Full Title of Study: “Prostanoid Therapy in Severe Pulmonary Arterial Hypertension – Imaging Control Study, 3D Echo, MR and RHC.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2019

Detailed Description

It is not possible to perform a magnetic resonance imaging in all patients and as a result echocardiography is not only done at screening but also during the follow up. The imaging technologies made a great progress in the last few years and enable a better assessment of the haemodynamic parameters in our days.

Arms, Groups and Cohorts

  • 3D echocardiography

Clinical Trial Outcome Measures

Primary Measures

  • right ventricular ejection fracture
    • Time Frame: month 12 (+/- 7 days)
    • right-sided heart catheterization

Secondary Measures

  • right atrial pressure
    • Time Frame: 12 month (+/- 7 days)
    • right-sided heart catheterization
  • cardiac index (CI)/cardiac output (CO)
    • Time Frame: 12 months (+/- 7 Days)
    • right-sided heart catheterization
  • pulmonary vascular resistance
    • Time Frame: 12 months (+/- 7 days)
    • right-sided heart catheterization
  • mean pulmonary capillary wedge pressure
    • Time Frame: 12 month (+/-7 days)
    • right-sided heart catheterization

Participating in This Clinical Trial

Inclusion Criteria

  • age >17 – pulmonary arterial hypertension WHO group I who are going to start a therapy with prostanoid – written informed consent – Prostanoid naive – no change of the pulmonary arterial hypertension therapy within 3 weeks of inclusion into the study Exclusion Criteria:

  • pregnancy and lactation period – Women of childbearing 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 a malignant disease)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Regina Steringer-Mascherbauer
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Regina Steringer-Mascherbauer, OA Dr. – Elisabethinen Hospital
  • Overall Official(s)
    • Regina Steringer-Mascherbauer, MD, Principal Investigator, Krankenhaus der Elisabethinen Linz GmbH
  • Overall Contact(s)
    • Regina Steringer-Mascherbauer, MD, 0043/732/7676, regina.mascherbauer@elisabethinen.or.at

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