Clinical trial NCT03231774: Comparability of Hemodynamic Parameters Measured by Non-invasive Echocardiography and by Right Heart Catheterization
Official title: Comparability of Hemodynamic Parameters Measured by Non-invasive Echocardiography and by Right Heart Catheterization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Echocardiography
Right heart catheterization
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled for transthoracic echocardiography and 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.

Eligibility criteria: Inclusion Criteria:

* Chronic heart failure NYHA I - IV

Exclusion Criteria:

-

Primary outcomes:
measure: Measurement of systolic, diastolic and mean CVP
timeFrame: During a single right heart catheterization procedure
Secondary outcomes:
measure: Measurement of systolic, diastolic and mean PAP
timeFrame: During a single right heart catheterization procedure
measure: Measurement of systolic, diastolic and mean RVP
timeFrame: During a single right heart catheterization procedure
measure: Measurement of systolic, diastolic and mean PAWP
timeFrame: During a single right heart catheterization procedure
measure: Measurement of Cardiac Index CI
timeFrame: During a single right heart catheterization procedure
measure: Measurement of Cardiac Output CO
timeFrame: During a single right heart catheterization procedure
measure: Transthoracic Echocardiography
timeFrame: During a single TTE examination
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
state: NRW
Study officials:
References:
citation: 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.2014.06.063.
citation: Szymczyk T, Sauzet O, Paluszkiewicz LJ, Costard-Jackle 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 Cardiovasc Imaging. 2020 Oct;36(10):1821-1829. doi: 10.1007/s10554-020-01889-3. Epub 2020 May 22.