Heart FailureNCT02977546
Noninvasive Pulse Contour Analysis for Hemodynamic Assessment in Patients With Chronic Heart Failure
An observational study of Heart Failure, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Noninvasive pulse contour analysis and Pulmonary artery catheterization
- Type of treatment
- Medical device
- How many people
- 107 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to Mar 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic heart failure NYHA >= 2 based on a reduced left ventricular ejection fraction (LV-EF <= 45%).
Who may be able to join
- chronic heart failure NYHA >= 2 based on a reduced left ventricular ejection fraction (LV-EF <= 45%)
- written consent
Who cannot join
- high-grade tricuspid insufficiency
- implantation of a ventricular assist device (VAD)
- NIBP difference >= 20 mmHg between left and right arm before investigation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Cardiology, Herz- und Diabetszentrum NRW, Ruhr-Universität Bochum
Bad Oeynhausen, 32545
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 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Noninvasive pulse contour analysis, Pulmonary artery catheterization
- Keywords
- Hemodynamics, Noninvasive, Pulse contour analysis, Heart failure, Swan Ganz Catheterization, Pulmonary artery Catheter
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive pulse contour analysisDevice
For noninvasive pulse contour Analysis we use the CNAP-Monitor (CNSystems Medizintechnik AG, Graz, Austria)
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Noninvasive pulse contour analysis; Device: Pulmonary artery catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output (l/min)
Three repeated and averaged measurements in a row of both methods within a range of <= 10%
Measured: 1 day
Secondary outcomes (3)
Cardiac index (l/min/m2)
Three repeated and averaged measurements in a row of both methods within a range of <= 10%
Measured: 1 day
Stroke volume (ml)
Three repeated and averaged measurements in a row of both methods within a range of <= 10%
Measured: 1 day
Systemic vascular resistance (dyn*sec/cm5)
Three repeated and averaged measurements in a row of both methods within a range of <= 10%
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Bitter, Heart and Diabetes Center North-Rhine Westfalia
- Investigators
- Thomas Bitter, Dr. med., Principal investigator, Heart and Diabetes Center NRW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977546
- Sponsor's protocol ID
- HDZNRW-KA_008_TB
- Status last verified
- Mar 2017
- First submitted
- 16 Nov 2016
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Pulse Contour Analysis for Hemodynamic Assessment in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT02977546
- Acronym / sponsor ID
- HDZNRW-KA_008_TB
- Conditions
- Heart Failure
- Keywords
- Hemodynamics, Noninvasive, Pulse contour analysis, Heart failure, Swan Ganz Catheterization, Pulmonary artery Catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure | – | Device: Noninvasive pulse contour analysis, Device: Pulmonary artery catheterizationPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic heart failure NYHA >= 2 based on a reduced left ventricular ejection fraction (LV-EF <= 45%).
Key inclusion criteria (2 listed)
- chronic heart failure NYHA >= 2 based on a reduced left ventricular ejection fraction (LV-EF <= 45%)
- written consent
Key exclusion criteria (3 listed)
- high-grade tricuspid insufficiency
- implantation of a ventricular assist device (VAD)
- NIBP difference >= 20 mmHg between left and right arm before investigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive pulse contour analysisFor noninvasive pulse contour Analysis we use the CNAP-Monitor (CNSystems Medizintechnik AG, Graz, Austria) | Device | Heart Failure |
| Pulmonary artery catheterizationAs a reference method we use the Goldstandard intermittent thermodilution via a PAC which is regularly performed during the patients Hospital stay | Device | Heart Failure |
Primary outcome
Cardiac Output (l/min)
Time frame: 1 day
Three repeated and averaged measurements in a row of both methods within a range of <= 10%
3 secondary outcomes
Cardiac index (l/min/m2)
Time frame: 1 day
Stroke volume (ml)
Time frame: 1 day
Systemic vascular resistance (dyn*sec/cm5)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Bitter, Dr. med. principal investigator
Heart and Diabetes Center NRW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output (l/min) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.