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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03231774

Enrollment

100

Registered

2017-07-27

Start date

2017-07-21

Completion date

2018-07-31

Last updated

2020-10-09

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

Conditions

Heart Failure

Keywords

Echocardiography, Right heart catheterization

Brief summary

This study is to compare transthoracic Echocardiography TTE to the gold standard Right Heart Catheterization in Terms of accuracy to measure hemodynamic parameters.

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.

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

* Chronic heart failure NYHA I - IV

Exclusion criteria

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results