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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02977546
• Other study ID #: HDZNRW-KA_008_TB
• Status: Completed
• Phase: N/A
• First received: November 16, 2016
• Last updated: March 14, 2017
• Start date: November 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Noninvasive pulse contour analysis
For noninvasive pulse contour Analysis we use the CNAP-Monitor (CNSystems Medizintechnik AG, Graz, Austria)
• Pulmonary artery catheterization
As a reference method we use the Goldstandard intermittent thermodilution via a PAC which is regularly performed during the patients Hospital stay

Locations

Country	Name	City	State
Germany	Clinic for Cardiology, Herz- und Diabetszentrum NRW, Ruhr-Universität Bochum	Bad Oeynhausen

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Between-Calibration-Drift	One measurement before and after a new calibration including finger change	1 day
Primary	Cardiac Output (l/min)	Three repeated and averaged measurements in a row of both methods within a range of <= 10%	1 day
Secondary	Cardiac index (l/min/m2)	Three repeated and averaged measurements in a row of both methods within a range of <= 10%	1 day
Secondary	Stroke volume (ml)	Three repeated and averaged measurements in a row of both methods within a range of <= 10%	1 day
Secondary	Systemic vascular resistance (dyn*sec/cm5)	Three repeated and averaged measurements in a row of both methods within a range of <= 10%	1 day