Clinical trial NCT02977546: Noninvasive Pulse Contour Analysis for Hemodynamic Assessment in Patients With Chronic Heart Failure
Official title: Noninvasive Pulse Contour Analysis for Hemodynamic Assessment in Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Hemodynamics
Noninvasive
Pulse contour analysis
Heart failure
Swan Ganz Catheterization
Pulmonary artery Catheter
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic heart failure NYHA \>= 2 based on a reduced left ventricular ejection fraction (LV-EF \<= 45%).

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac Output (l/min)
timeFrame: 1 day
Secondary outcomes:
measure: Cardiac index (l/min/m2)
timeFrame: 1 day
measure: Stroke volume (ml)
timeFrame: 1 day
measure: Systemic vascular resistance (dyn*sec/cm5)
timeFrame: 1 day
Other outcomes:
measure: Between-Calibration-Drift
timeFrame: 1 day
Locations:
city: Bad Oeynhausen
country: Germany
facility: Clinic for Cardiology, Herz- und Diabetszentrum NRW, Ruhr-Universität Bochum
Study officials:
affiliation: Heart and Diabetes Center NRW
name: Thomas Bitter, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: