NCT02977546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

November 16, 2016

Last Update Submit

March 14, 2017

Conditions

Heart Failure

Keywords

HemodynamicsNoninvasivePulse contour analysisHeart failureSwan Ganz CatheterizationPulmonary artery Catheter

Outcome Measures

Primary Outcomes (1)

  • Cardiac Output (l/min)

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

    1 day

Secondary Outcomes (3)

  • Cardiac index (l/min/m2)

    1 day

  • Stroke volume (ml)

    1 day

  • Systemic vascular resistance (dyn*sec/cm5)

    1 day

Other Outcomes (1)

  • Between-Calibration-Drift

    1 day

Study Arms (1)

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 analysisDevice: Pulmonary artery catheterization

Interventions

Noninvasive pulse contour analysisDEVICE

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

Heart Failure
Pulmonary artery catheterizationDEVICE

As a reference method we use the Goldstandard intermittent thermodilution via a PAC which is regularly performed during the patients Hospital stay

Heart Failure

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic heart failure NYHA \>= 2 based on a reduced left ventricular ejection fraction (LV-EF \<= 45%).

You may qualify if:

  • chronic heart failure NYHA \>= 2 based on a reduced left ventricular ejection fraction (LV-EF \<= 45%)
  • written consent

You may not qualify if:

  • high-grade tricuspid insufficiency
  • implantation of a ventricular assist device (VAD)
  • NIBP difference \>= 20 mmHg between left and right arm before investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bad Oeynhausen, 32545, Germany

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Catheterization, Swan-Ganz

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac CatheterizationHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisCatheterization, PeripheralCatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Thomas Bitter, Dr. med.

    Heart and Diabetes Center NRW

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Consultant for Cardiology and Pneumology, Doctor of medicine

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 30, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 15, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)