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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02198456

Acronym

PARIS

Enrollment

Registered

2014-07-23

Start date

2014-07-31

Completion date

2019-12-31

Last updated

2018-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension WHO Group I

Keywords

pulmonary arterial hypertension

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

Austria

Contacts

Primary ContactRegina Steringer-Mascherbauer, MD

regina.mascherbauer@elisabethinen.or.at0043/732/7676

Backup ContactAndrea Ploechl

andrea.ploechl@elisabethinen.or.at0043/732/7676

Outcome results