NCT01606839

Brief Summary

The study hypothesis is that accuracy of CO measurement by IGR does not differ from classical CO measurement methods such as thermodilution or direct Fick method. This is why the study aims to determine whether non invasive cardiac output (CO) measurement using inert gas rebreathing (IGR)is a suitable method in patients with pulmonary hypertension. In order to examine this, the IGR method will be used in patients undergoing diagnostic or follow-up right heart catheterization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

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

February 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

May 24, 2012

Last Update Submit

February 18, 2014

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Cardiac output

    at baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients undergoing diagnostic or follow-up right heart cathereization.

You may qualify if:

  • Written informed consent
  • Patients who undergo right heart catheterization

You may not qualify if:

  • Missing written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig Boltzmann Institute for Lung Vascular Research

Graz, 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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2012

First Posted

May 28, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

AU(1)