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

March 14, 2017 updated by: Thomas Bitter, Heart and Diabetes Center North-Rhine Westfalia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Clinic for Cardiology, Herz- und Diabetszentrum NRW, Ruhr-Universität Bochum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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%).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heart Failure
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
For noninvasive pulse contour Analysis we use the CNAP-Monitor (CNSystems Medizintechnik AG, Graz, Austria)
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Output (l/min)
Time Frame: 1 day
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)
Time Frame: 1 day
Three repeated and averaged measurements in a row of both methods within a range of <= 10%
1 day
Stroke volume (ml)
Time Frame: 1 day
Three repeated and averaged measurements in a row of both methods within a range of <= 10%
1 day
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%
1 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between-Calibration-Drift
Time Frame: 1 day
One measurement before and after a new calibration including finger change
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Investigators

  • Principal Investigator: Thomas Bitter, Dr. med., Heart and Diabetes Center NRW

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 25, 2016

First Posted (Estimate)

November 30, 2016

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 14, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDZNRW-KA_008_TB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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