NCT01607515

Brief Summary

Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25 mmHg in the right heart catheterization. There are different forms of PH defined in the classification of Dana Point 2008. PH is diagnosed with right heart catheterization but there are other non invasive methods which can be used for screening like echocardiography, stress echocardiography and cardio pulmonary exercise testing. For prognosis of PH patients the limitation of the pulmonary circulation is very important. Therefore the cardiac index (CI) is a good parameter for the right ventricular function. The gold standard for CI measures is the thermodilution, an invasive method performed during right heart catheterization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

3.3 years

First QC Date

April 13, 2012

Last Update Submit

September 7, 2015

Conditions

Pulmonary Hypertension

Keywords

Pulmonary hypertensionCardiac indeximpedance cardiography

Outcome Measures

Primary Outcomes (1)

  • Comparison of CI measured by ICG and Thermodilution

    assessment of the Specificity and sensitivity of ICG for CI measurement

    recruitment over 1.5 year (Data collection), followed by data analysis and interpretation (overall 2 yearsfrom start of recruitment)

Study Arms (1)

suspected PH

OTHER

Patients who undergo right heart catheterization for PH diagnosis undergo impedance cardiography

Other: Impedance cardiography

Interventions

Impedance cardiographyOTHER

noninvasive measure of cardiac index by impedance cardiography.

Also known as: patients with a clinical suspicion of PH
suspected PH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who have right heart catheterization written informed consent

You may not qualify if:

  • patients who don't have right heart catheterization no written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Horst Olschewski, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2012

First Posted

May 30, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

AU(1)