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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231774
• Other study ID #: HDZ-KA_011_HF
• Status: Completed
• Start date: July 21, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: September 2018
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic heart failure NYHA I - IV

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Fox H, Puehler T, Schulz U, Bitter T, Horstkotte D, Oldenburg O. Delayed recovery from Cheyne-Stokes respiration in heart failure after successful cardiac transplantation: a case report. Transplant Proc. 2014 Sep;46(7):2462-3. doi: 10.1016/j.transproceed. — View Citation

Szymczyk T, Sauzet O, Paluszkiewicz LJ, Costard-Jäckle A, Potratz M, Rudolph V, Gummert JF, Fox H. Non-invasive assessment of central venous pressure in heart failure: a systematic prospective comparison of echocardiography and Swan-Ganz catheter. Int J C — View Citation

Outcome

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