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

Completed

• Conditions: Heart Failure
• Interventions: Device: Noninvasive pulse contour analysis; Device: Pulmonary artery catheterization

• Registration Number: NCT02977546
• Lead Sponsor: Heart and Diabetes Center North-Rhine Westfalia

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-25
• Study First Posted: 2016-11-30
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart Failure	Pulmonary artery catheterization	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.
Heart Failure	Noninvasive pulse contour analysis	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.

Primary Outcome Measures

Name	Time	Method
Cardiac Output (l/min)	1 day	Three repeated and averaged measurements in a row of both methods within a range of \<= 10%

Secondary Outcome Measures

Name	Time	Method
Stroke volume (ml)	1 day	Three repeated and averaged measurements in a row of both methods within a range of \<= 10%
Systemic vascular resistance (dyn*sec/cm5)	1 day	Three repeated and averaged measurements in a row of both methods within a range of \<= 10%
Cardiac index (l/min/m2)	1 day	Three repeated and averaged measurements in a row of both methods within a range of \<= 10%

Trial Locations

Locations (1)

Clinic for Cardiology, Herz- und Diabetszentrum NRW, Ruhr-Universität Bochum; 🇩🇪 Bad Oeynhausen, Germany