Imaging Control Study, 3D Echo, MR and RHC. (PARIS)

Prostanoid Therapy in Severe Pulmonary Arterial Hypertension - Imaging Control Study, 3D Echo, MR and RHC.

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Arterial Hypertension WHO Group I

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.

• Study Type: Observational
• Enrollment (Anticipated): 12

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

pulmonary arterial hypertension WHO group I

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
3D echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
right ventricular ejection fracture	right-sided heart catheterization	month 12 (+/- 7 days)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Regina Steringer-Mascherbauer

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (ESTIMATE): July 23, 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

• Keywords: pulmonary arterial hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: Protocol PARIS3D

Plan for Individual participant data (IPD)

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