Noninvasive Pulse Contour Analysis for Hemodynamic Assessment in Patients With Chronic Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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Noninvasive Pulse Contour Analysis for Hemodynamic Assessment in Patients With Chronic Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Noninvasive pulse contour analysis
* Device: Pulmonary artery catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic heart failure NYHA >= 2 based on a reduced left ventricular ejection fraction (LV-EF <= 45%) written consent Exclusion Criteria: high-grade tricuspid insufficiency implantation of a ventricular assist device (VAD) NIBP difference >= 20 mmHg between left and right arm before investigation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart Failure<br>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. | Device: Noninvasive pulse contour analysis<br>* For noninvasive pulse contour Analysis we use the CNAP-Monitor (CNSystems Medizintechnik AG, Graz, Austria)<br>Device: Pulmonary artery catheterization<br>* As a reference method we use the Goldstandard intermittent thermodilution via a PAC which is regularly performed during the patients Hospital stay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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% | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodynamics, Noninvasive, Pulse contour analysis, Heart failure, Swan Ganz Catheterization, Pulmonary artery Catheter