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

Completed

• Conditions: Heart Failure

• Registration Number: NCT03231774
• Lead Sponsor: Heart and Diabetes Center North-Rhine Westfalia

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.

Study Timeline

• Study First Submitted: 2017-06-26
• Study Start: 2017-07-21
• Study First Submitted QC: 2017-07-24
• Study First Posted: 2017-07-27
• Primary Completion: 2017-12-31
• Study Completion: 2018-07-31
• Status Verified: 2018-09
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Chronic heart failure NYHA I - IV

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of systolic, diastolic and mean CVP	During a single right heart catheterization procedure	CVP measured in mmHg

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, NRW, Germany