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Completed

NCT Number: NCT02977546

Noninvasive Pulse Contour Analysis for Hemodynamic Assessment 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 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic for Cardiology, Herz- und Diabetszentrum NRW, Ruhr-Universität Bochum

Bad Oeynhausen, 32545, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noninvasive pulse contour analysis

Device

For noninvasive pulse contour Analysis we use the CNAP-Monitor (CNSystems Medizintechnik AG, Graz, Austria)

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

Primary outcomes

  1. Cardiac Output (l/min)

    Time frame: 1 day

    Three repeated and averaged measurements in a row of both methods within a range of <= 10%

Secondary outcomes

  1. Cardiac index (l/min/m2)

    Time frame: 1 day

    Three repeated and averaged measurements in a row of both methods within a range of <= 10%

  2. Stroke volume (ml)

    Time frame: 1 day

    Three repeated and averaged measurements in a row of both methods within a range of <= 10%

  3. Systemic vascular resistance (dyn*sec/cm5)

    Time frame: 1 day

    Three repeated and averaged measurements in a row of both methods within a range of <= 10%

Other outcomes

  1. Between-Calibration-Drift

    Time frame: 1 day

    One measurement before and after a new calibration including finger change

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 30, 2016
Registry last updated
Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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