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Determination of hemodynamics plays an important role in the diagnosis of chronic heart failure. The gold standard is intermittent thermodilution via pulmonary artery catheter (PAC). Because of its invasiveness, there are certain risks of this method, e.g. injuries to the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc. Noninvasive pulse contour Analysis (NPCA) is a new method which is able to determine hemodynamics noninvasively via a simple finger cuff. Advantages towards pulmonary artery Catheterization include a lower risk and an operator-Independent easy handling. Some studies investigated the accuracy, precision and trending abilities of noninvasive pulse contour analysis during anesthesia and in the intensive care unit, but there is no data available for its use in patients with chronic heart failure. The investigators therefore initiated this Trial to verify if NPCA is suitable for Determination of hemodynamics in patients with chronic heart failure.
Determination of hemodynamics plays an important role in the diagnosis of chronic heart failure. The gold standard is intermittent thermodilution via pulmonary artery catheter (PAC). Because of its invasiveness, there are certain risks of this method, e.g. injuries to the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc. Noninvasive pulse contour Analysis (NPCA) is a new method which is able to determine hemodynamics noninvasively via a finger cuff. Advantages towards pulmonary artery Catheterization include a lower risk and an operator-Independent easy handling. Some studies investigated the accuracy, precision and trend abilities of noninvasive pulse contour analysis during anesthesia and in the intensive care unit, but there is no data for its use in patients with chronic heart failure. The investigators therefore initiated this Trial to verify if NPCA is suitable for Determination of hemodynamics in patients with chronic heart failure. For NPCA the investigators use the CNAP monitor (CNSystems Medizintechnik AG). As a reference method the investigators use intermittent thermodilution via PAC (TD). Three averaged autocalibrated NPCA-CO-measurements are going to be validated against three averaged TD-CO-measurements. Moreover, measurements of cardiac index, stroke volume, systemic vascular resistance and a between-calibration-drift will be performed. The investigators will assess the accuracy and precision of the individual values.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Failure | Patients with chronic heart failure NYHA >= 2 based on a reduced left ventricular ejection fraction (LV-EF <= 45%). All patients receive pulmonary artery catheterization and noninvasive pulse contour Analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive pulse contour analysis | Device | For noninvasive pulse contour Analysis we use the CNAP-Monitor (CNSystems Medizintechnik AG, Graz, Austria) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output (l/min) | Three repeated and averaged measurements in a row of both methods within a range of <= 10% | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac index (l/min/m2) | Three repeated and averaged measurements in a row of both methods within a range of <= 10% | 1 day |
| Stroke volume (ml) | Three repeated and averaged measurements in a row of both methods within a range of <= 10% |
| Measure | Description | Time Frame |
|---|---|---|
| Between-Calibration-Drift | One measurement before and after a new calibration including finger change | 1 day |
Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic heart failure NYHA >= 2 based on a reduced left ventricular ejection fraction (LV-EF <= 45%).
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Bitter, Dr. med. | Heart and Diabetes Center NRW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Cardiology, Herz- und Diabetszentrum NRW, Ruhr-Universität Bochum | Bad Oeynhausen | 32545 | Germany |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002407 | Catheterization, Swan-Ganz |
| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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| Pulmonary artery catheterization | Device | As a reference method we use the Goldstandard intermittent thermodilution via a PAC which is regularly performed during the patients Hospital stay |
|
| 1 day |
| Systemic vascular resistance (dyn*sec/cm5) | Three repeated and averaged measurements in a row of both methods within a range of <= 10% | 1 day |
| D003933 | Diagnosis |
| D002406 | Catheterization, Peripheral |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |