Heart DiseasesPhase 4NCT02035007
Transpulmonary Thermodilution Measurements in Patients With Heart Diseases
A Phase 4 study testing PiCCO Catheter (Pulsiocath 5F) in people with Heart Diseases, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to examine the validation of the PiCCO (Pulse Contour Cardiac Output)-derived transpulmonary thermodilution technology in patients with heart diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- PiCCO Catheter (Pulsiocath 5F)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2009to Dec 2014
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary heart disease without impaired left ventricular function [LV-EF > 50%] (n=10, control group)
- Coronary heart disease with impaired left ventricular function [LV-EF < 50%] (n=10)
- Dilated cardiomyopathy (n=10),
- Aortic valve stenosis (n=10),
- Mitral valve regurgitation (n=10),
- Diastolic left ventricular dysfunction (n=10) and
- Right heart failure (n=10)
Who cannot join
- Patients with catecholamine dependent cardiogenic shock, severe respiratory distress because of pulmonary oedema, intubated patients, patients with atrial fibrillation, atrioventricular conduction abnormalities, and slow ventricular tachycardia will not be included.
- Moreover patients not being able to give informed consent are excluded. Even more, pregnant women are excluded from the study due to the radiation exposure in line with heart catheterization. A pregnancy test will be performed prior to participating with this study.
- The age does not represent an exclusion criterion.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Medical Intensive Care Unit, University Hospital of Zurich
Zurich, Canton of Zurich, 8091
About this study
The purpose of this study is to examine the validation of the PiCCO (Pulse Contour Cardiac Output)-derived transpulmonary thermodilution technology in patients with heart diseases.
Read the detailed description
- How do PiCCO and PAC (pulmonary artery catheter) derived hemodynamic variables change in different cardiac pathologies?
- How do PiCCO hemodynamic variables compare to transthoracic echocardiographic parameters in different cardiac pathologies?
- How does GEDV (global enddiastolic volume) correlate with left ventricles end-diastolic volume (LVEDV) assessed by LV (left ventricle) ventriculography and echocardiography?
- How do PiCCO cardiac function variables (GEF [global ejection fraction]; CFI [cardiac function index]) correlate with LV dP/dt max, LVEF (left ventricular ejection fraction) assessed by LV ventriculography and echocardiography, LVFAC (left ventricular fractional area of change), LV stroke work index (LVSWI) and cardiac power (CP)?
- How does GEDV compare to LVEDV and left ventricular end-diastolic pressure (LVEDP) as assessed by the pulmonary artery occlusion pressure (PAOP)?
- How does right ventricular function influence GEDV, GEF and CFI?
- Conditions
- Heart Diseases
- Being tested
- PiCCO Catheter (Pulsiocath 5F)
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiCCO Catheter (Pulsiocath 5F)Device
Also called Pulsiocath 5F, Pulsion Medical Systems, Munich, Germany
Measuring of PiCCO derived values
| Study group | Role | What they receive |
|---|---|---|
| LV-EF > 50% | Experimental | PiCCO catheter analysis of patients with coronary heart disease without impaired left ventricular function [LV-EF > 50%] Receives: Device: PiCCO Catheter (Pulsiocath 5F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output, Preload values (GEDV)
Outcome measure is obtained during PiCCO measurement and left/right heart catherization, respectively ("point-of-care" measurement). There is no follow-up examination thereafter.
Measured: Day 1 only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJul 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Maggiorini, Prof MD, Principal investigator, University Hospital Zurich, Medical Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035007
- Sponsor's protocol ID
- Version 2, 17.04.09 / EK1649
- Status last verified
- Jun 2015
- First submitted
- 2 Oct 2009
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transpulmonary Thermodilution Measurements in Patients With Heart Diseases
- ClinicalTrials.gov ID
- NCT02035007
- Acronym / sponsor ID
- Version 2, 17.04.09 / EK1649
- Conditions
- Heart Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Jan 2014 (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.
The purpose of this study is to examine the validation of the PiCCO (Pulse Contour Cardiac Output)-derived transpulmonary thermodilution technology in patients with heart diseases.
Detailed description
- How do PiCCO and PAC (pulmonary artery catheter) derived hemodynamic variables change in different cardiac pathologies?
- How do PiCCO hemodynamic variables compare to transthoracic echocardiographic parameters in different cardiac pathologies?
- How does GEDV (global enddiastolic volume) correlate with left ventricles end-diastolic volume (LVEDV) assessed by LV (left ventricle) ventriculography and echocardiography?
- How do PiCCO cardiac function variables (GEF [global ejection fraction]; CFI [cardiac function index]) correlate with LV dP/dt max, LVEF (left ventricular ejection fraction) assessed by LV ventriculography and echocardiography, LVFAC (left ventricular fractional area of change), LV stroke work index (LVSWI) and cardiac power (CP)?
- How does GEDV compare to LVEDV and left ventricular end-diastolic pressure (LVEDP) as assessed by the pulmonary artery occlusion pressure (PAOP)?
- How does right ventricular function influence GEDV, GEF and CFI?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LV-EF > 50% | Experimental | Device: PiCCO Catheter (Pulsiocath 5F)PiCCO catheter analysis of patients with coronary heart disease without impaired left ventricular function [LV-EF > 50%] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Coronary heart disease without impaired left ventricular function [LV-EF > 50%] (n=10, control group)
- Coronary heart disease with impaired left ventricular function [LV-EF < 50%] (n=10)
- Dilated cardiomyopathy (n=10),
- Aortic valve stenosis (n=10),
- Mitral valve regurgitation (n=10),
Key exclusion criteria (3 listed)
- Patients with catecholamine dependent cardiogenic shock, severe respiratory distress because of pulmonary oedema, intubated patients, patients with atrial fibrillation, atrioventricular conduction abnormalities, and slow ventricular tachycardia will not be included.
- Moreover patients not being able to give informed consent are excluded. Even more, pregnant women are excluded from the study due to the radiation exposure in line with heart catheterization. A pregnancy test will be performed prior to participating with this study.
- The age does not represent an exclusion criterion.
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 |
|---|---|---|
| PiCCO Catheter (Pulsiocath 5F)Also: Pulsiocath 5F, Pulsion Medical Systems, Munich, GermanyMeasuring of PiCCO derived values | Device | LV-EF > 50% |
Primary outcome
Cardiac Output, Preload values (GEDV)
Time frame: Day 1 only
Outcome measure is obtained during PiCCO measurement and left/right heart catherization, respectively ("point-of-care" measurement). There is no follow-up examination thereafter.
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 26 Jun 2015.
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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.
Marco Maggiorini, Prof MD principal investigator
University Hospital Zurich, Medical Intensive Care Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PiCCO Catheter (Pulsiocath 5F) in people with Heart Diseases, run by University of Zurich at 1 site in Switzerland.
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 7 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 26 Jun 2015. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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, Preload values (GEDV) (time frame: Day 1 only). 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 26 Jun 2015.