Comparability of Hemodynamic Parameters Measured by Non-invasive Echocardiography and by Right Heart Catheterization

October 7, 2020 updated by: Heart and Diabetes Center North-Rhine Westfalia
This study is to compare transthoracic Echocardiography TTE to the gold standard Right Heart Catheterization in Terms of accuracy to measure hemodynamic parameters.

Study Overview

Status

Completed

Conditions

Detailed Description

Chronic heart failure is a progressive disease in Western population. Echocardiography and right heart catheterization are important tools in the diagnosis and progress monitoring of heart failure.

Gold standard in diagnosis of hemodynamic parameters in patients with heart failure is right heart catheterization. However, this diagnostic device represents an invasive method that is additionally associated with high risks such as infections, vessel and nerve injuries. Echocardiography is probably in a position to determine hemodynamic parameters as reliably as right heart catheterization without additional health risk due to its non-invasive character. All procedures performed are part of clinical Routine. Patients do not undergo any study-specific procedure at all.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Bad Oeynhausen, NRW, Germany, 32545
        • Herz- und Diabeteszentrum NRW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients scheduled for transthoracic echocardiography and right heart catheterization.

Description

Inclusion Criteria:

  • Chronic heart failure NYHA I - IV

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of systolic, diastolic and mean CVP
Time Frame: During a single right heart catheterization procedure
CVP measured in mmHg
During a single right heart catheterization procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of systolic, diastolic and mean PAP
Time Frame: During a single right heart catheterization procedure
PAP measured in mmHg
During a single right heart catheterization procedure
Measurement of systolic, diastolic and mean RVP
Time Frame: During a single right heart catheterization procedure
RVP measured in mmHg
During a single right heart catheterization procedure
Measurement of systolic, diastolic and mean PAWP
Time Frame: During a single right heart catheterization procedure
PAWP measured in mmHg
During a single right heart catheterization procedure
Measurement of Cardiac Index CI
Time Frame: During a single right heart catheterization procedure
CI measured in l/M/m²
During a single right heart catheterization procedure
Measurement of Cardiac Output CO
Time Frame: During a single right heart catheterization procedure
CO measured in l/min
During a single right heart catheterization procedure
Transthoracic Echocardiography
Time Frame: During a single TTE examination
Collected data will be analyzed for comparability
During a single TTE examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2017

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

July 31, 2018

Study Registration Dates

First Submitted

June 26, 2017

First Submitted That Met QC Criteria

July 24, 2017

First Posted (Actual)

July 27, 2017

Study Record Updates

Last Update Posted (Actual)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDZ-KA_011_HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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