Cardiogenic ShockNCT06330597
NIVIA-Hemodynamics
An observational study of Cardiogenic Shock and Heart Failure, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is an investigator-initiated, single-center, single-arm prospective study to compare non-invasive hemodynamic assessment using transthoracic echocardiography (TTE) and lung ultrasound (LUS) and hemodynamic assessment using PAC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Heart Failure, Shock
- What is being tested?
- Echocardiography and lung ultrasound
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jul 2021to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be composed of patients admitted to the Coronary Intensive Care Unit (CICU) requiring hemodynamic assessment using pulmonary artery catheter (PAC) as standard of care.
Who may be able to join
- Patients with admitted to the CICU in whom PAC is inserted as standard of care,
Who cannot join
- Enrollment into another trial with an active treatment arm
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2N2
Yishay Szekely, MD, 4163404800, Yishay.szekely@uhn.ca
About this study
Official title: Noninvasive Versus Invasive Assessment of Hemodynamics in the Cardiac Intensive Care Unit
This is an investigator-initiated, single-center, single-arm prospective study to compare non-invasive hemodynamic assessment using transthoracic echocardiography (TTE) and lung ultrasound (LUS) and hemodynamic assessment using PAC. Patients who have been hemodynamically assessed using PAC will be invited to participate. Each patient will undergo TTE and LUS immediately after first invasive assessment, and again daily after PAC assessments.
Read the detailed description
Background
Heart Failure
Approximately 600,000 Canadians are living with heart failure (HF) with 50,000 new patients diagnosed each year. Once diagnosed, the median survival for HF patients is 1.7 years for men and 3.2 years for women. As HF progresses, patients experience a worsening in symptom severity, functional capacity, and quality of life. In addition, acute exacerbations of HF is the most frequent cause of unscheduled hospital admissions. Almost 83% of all HF patients will be hospitalized at least once and 43% hospitalized more than three times. However, the mechanisms of HF decompensation are still unclear.
Most drugs (ACE-I/ARB/beta-blockers/MRA) used for the treatment of HF are prescribed because of their ability to improve symptoms or survival. The target doses of these drugs are generally selected on the basis of reported results from randomized controlled trials rather than changes produced in cardiac monitoring of hemodynamics. Interestingly, hemodynamic monitoring has been reportedly indicated in patients where it is difficult to determine their volume status, in addition to those patients refractory to therapy. The ACC/AHA 2013 guidelines3 define the importance of invasive hemodynamic monitoring in patients with:
- severe clinical decompensation in which therapy is limited by elevated filling pressures, hypoperfusion, and vascular tone
- persistent severe symptoms despite a trial of recommended therapies
- the needed or dependency for (or escalation of) pressor and inotropic therapy
Cardiogenic shock
Cardiogenic shock (CS) is a state of profound HF resulting in peripheral organ hypoperfusion, injury and failure. The precipitating events leading to CS are diverse. Patients may experience CS as a slow progression of chronic HF. More frequently however; patients experience CS after an acute cardiac insult such as an acute myocardial infarction, myocarditis or malignant ventricular arrhythmia. It is inevitable that patients who develop CS will die if treatment is not initiated rapidly. In addition, if initial medical therapy fails to maintain adequate cardiac output, initiation of mechanical circulatory support (MCS) represents a life-saving strategy. There has been no established role for the use of invasive hemodynamic measurements in the management of patients with HF. And yet, patients with CS being considered for cardiac transplantation or placement of an MCS device are required to undergo right-heart catheterization using pulmonary artery catheter (PAC), including an assessment of right heart filling pressures, pulmonary artery pressures, left heart filling pressures and cardiac output.
University Health Network (UHN) has the largest and most comprehensive MCS program in Canada. As clinicians working at the Peter Munk Cardiac Centre (PMCC) we are caring for an ever-increasing number of patients with profound refractory cardiogenic shock who require invasive hemodynamic assessment.
Rationale for the study
The majority of patients who present to the CICU require invasive hemodynamic assessment as part of their usual care. To assist in the management of these critically ill patients, the investigators need a complete understanding of the hemodynamic status. Currently, this is usually done invasively by placing a PAC. Alternatively, a non-invasive assessment using transthoracic echocardiography (TTE) can be pursued.
Pulmonary artery Catheter
In early retrospective registries, there was no benefit shown for the use of PAC. However, this had not been studied in patients with CS until recently. In a large retrospective study of CS patients, the use of PAC was associated with improved survival (30% vs 38%). This study provided the basis for the incorporation of PAC into CS treatment algorithms. In addition, the guidelines and scientific statements limited recommendations regarding PAC to use in patients with CS. The hemodynamic data obtained with a PAC can facilitate clinical decision-making and allow customization of a treatment plan through the optimization of medical therapy. However, as with any invasive diagnostic tool, the benefit must be balanced against risks. Complications of PAC include central venous access-related adverse events (<3.6%), arrhythmias and heart block (0.3% to 3.8%), and pulmonary artery rupture (0.02% to 0.03%).
Transthoracic echocardiography
TTE is a non-invasive ultrasound-based diagnostic tool that has the ability to also evaluate and track both RV and LV hemodynamic status. There is conflicting evidence of the utility of TTE monitoring in reflecting the hemodynamic changes in PAC-derived hemodynamic measurements.
Lung Ultrasound (LUS)
LUS allows for a rapid point-of-care evaluation of a number of conditions, including pulmonary edema, lung consolidation, pleural effusion, and pneumothorax. High intra-rater and inter-rater reproducibility, ease of learning, short exam duration (<5 min), and the noninvasive nature of this technique makes it an advantageous point-of-care tool. LUS is increasingly used in the acute care setting, and has improved diagnostic accuracy compared with clinical assessment and chest radiography for the identification of a cardiac aetiology in patients presenting to the emergency department with undifferentiated dyspnea. Quantification of B-lines (vertical artefacts that result from an increase in interstitial density) has been shown to be useful for the diagnosis, monitoring, and risk assessment of patients with known or suspected ADHF. Either curvilinear or phased array transducers can be used, typically at an imaging depth of 14-18 cm.
Hypothesis
The investigators hypothesize that non-invasive hemodynamic parameters derived from TTE would be comparable to those obtained invasively by PAC in patient admitted to the CICU. The investigators also hypothesize that there will be a strong correlation between intracardiac pressures and the severity of pulmonary congestion as evaluated by LUS.
- Conditions
- Cardiogenic Shock, Heart Failure, Shock, Hemodynamic Instability
- Being tested
- Echocardiography and lung ultrasound
- Keywords
- Pulmonary Artery Catheter, Lung Ultrasound, Echocardiography
- Medical subject headings
- Shock, Cardiogenic, Heart Failure, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography and lung ultrasoundDiagnostic test
All patients will undergo non-invasive echocardiogram and lung ultrasound at times of assessment of hemodynamic parameters as needed by usual clinical management.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to CICU | The study population will be composed of patients admitted to the Coronary Intensive Care Unit (CICU) requiring hemodynamic assessment using pulmonary artery catheter (PAC) as standard of care. Receives: Diagnostic Test: Echocardiography and lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between E/e' ratio and PCWP vs. correlation between lung ultrasound score and PCWP.
To determine whether non-invasive assessment of hemodynamics by echocardiogram are comparable to invasive measurements.
Measured: Day 1
Secondary outcomes (7)
Correlation between cardiac output measured by echocardiography (using LVOT diameter and VTI) and by PAC (using thermodilution)
To correlate cardiac and pulmonary pressures derived from invasive measurements with lung ultrasound findings.
Measured: Day 1, Day 2
Correlation between right atrial pressure assessed by echocardiography (using IVC diameter and respiratory variation) and by PAC
To correlate cardiac and pulmonary pressures derived from invasive measurements with lung ultrasound findings.
Measured: Day 1, Day 2
Correlation between pulmonary pressure assessed by echocardiography (using TR max velocity and estimated RAP) and by PAC
To correlate cardiac and pulmonary pressures derived from invasive measurements with lung ultrasound findings.
Measured: Day 1, Day 2
Correlation between pulmonary pressure assessed by echocardiography (using PAT) and by PAC
To correlate cardiac and pulmonary pressures derived from invasive measurements with lung ultrasound findings.
Measured: Day 1, Day 2
Correlation between PVR assessed by echocardiography (using PAT) and by PAC
To correlate cardiac and pulmonary pressures derived from invasive measurements with lung ultrasound findings.
Measured: Day 1, Day 2
Correlation between right ventricular function assessed by echocardiography (using TAPSE and S') and by PAC (using PAPI and RVSWI)
To correlate cardiac and pulmonary pressures derived from invasive measurements with lung ultrasound findings.
Measured: Day 1, Day 2
Correlation between E/e' ratio and PCWP vs. correlation between lung ultrasound score and PCWP.
To determine whether non-invasive assessment of hemodynamics by echocardiogram are comparable to invasive measurements.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start17 Jul 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filio Billia, MD PhD, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330597
- Sponsor's protocol ID
- 21-5196
- Status last verified
- Mar 2024
- First submitted
- 30 May 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Versus Invasive Assessment of Hemodynamics in the Cardiac Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06330597
- Acronym / sponsor ID
- 21-5196
- Conditions
- Cardiogenic Shock, Heart Failure, Shock, Hemodynamic Instability
- Keywords
- Pulmonary Artery Catheter, Lung Ultrasound, Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 17 Jul 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Mar 2024 (actual)
- 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.
This is an investigator-initiated, single-center, single-arm prospective study to compare non-invasive hemodynamic assessment using transthoracic echocardiography (TTE) and lung ultrasound (LUS) and hemodynamic assessment using PAC. Patients who have been hemodynamically assessed using PAC will be invited to participate. Each patient will undergo TTE and LUS immediately after first invasive assessment, and again daily after PAC assessments.
Detailed description
Background
Heart Failure
Approximately 600,000 Canadians are living with heart failure (HF) with 50,000 new patients diagnosed each year. Once diagnosed, the median survival for HF patients is 1.7 years for men and 3.2 years for women. As HF progresses, patients experience a worsening in symptom severity, functional capacity, and quality of life. In addition, acute exacerbations of HF is the most frequent cause of unscheduled hospital admissions. Almost 83% of all HF patients will be hospitalized at least once and 43% hospitalized more than three times. However, the mechanisms of HF decompensation are still unclear.
Most drugs (ACE-I/ARB/beta-blockers/MRA) used for the treatment of HF are prescribed because of their ability to improve symptoms or survival. The target doses of these drugs are generally selected on the basis of reported results from randomized controlled trials rather than changes produced in cardiac monitoring of hemodynamics. Interestingly, hemodynamic monitoring has been reportedly indicated in patients where it is difficult to determine their volume status, in addition to those patients refractory to therapy. The ACC/AHA 2013 guidelines3 define the importance of invasive hemodynamic monitoring in patients with:
- severe clinical decompensation in which therapy is limited by elevated filling pressures, hypoperfusion, and vascular tone
- persistent severe symptoms despite a trial of recommended therapies
- the needed or dependency for (or escalation of) pressor and inotropic therapy
Cardiogenic shock
Cardiogenic shock (CS) is a state of profound HF resulting in peripheral organ hypoperfusion, injury and failure. The precipitating events leading to CS are diverse. Patients may experience CS as a slow progression of chronic HF. More frequently however; patients experience CS after an acute cardiac insult such as an acute myocardial infarction, myocarditis or malignant ventricular arrhythmia. It is inevitable that patients who develop CS will die if treatment is not initiated rapidly. In addition, if initial medical therapy fails to maintain adequate cardiac output, initiation of mechanical circulatory support (MCS) represents a life-saving strategy. There has been no established role for the use of invasive hemodynamic measurements in the management of patients with HF. And yet, patients with CS being considered for cardiac transplantation or placement of an MCS device are required to undergo right-heart catheterization using pulmonary artery catheter (PAC), including an assessment of right heart filling pressures, pulmonary artery pressures, left heart filling pressures and cardiac output.
University Health Network (UHN) has the largest and most comprehensive MCS program in Canada. As clinicians working at the Peter Munk Cardiac Centre (PMCC) we are caring for an ever-increasing number of patients with profound refractory cardiogenic shock who require invasive hemodynamic assessment.
Rationale for the study
The majority of patients who present to the CICU require invasive hemodynamic assessment as part of their usual care. To assist in the management of these critically ill patients, the investigators need a complete understanding of the hemodynamic status. Currently, this is usually done invasively by placing a PAC. Alternatively, a non-invasive assessment using transthoracic echocardiography (TTE) can be pursued.
Pulmonary artery Catheter
In early retrospective registries, there was no benefit shown for the use of PAC. However, this had not been studied in patients with CS until recently. In a large retrospective study of CS patients, the use of PAC was associated with improved survival (30% vs 38%). This study provided the basis for the incorporation of PAC into CS treatment algorithms. In addition, the guidelines and scientific statements limited recommendations regarding PAC to use in patients with CS. The hemodynamic data obtained with a PAC can facilitate clinical decision-making and allow customization of a treatment plan through the optimization of medical therapy. However, as with any invasive diagnostic tool, the benefit must be balanced against risks. Complications of PAC include central venous access-related adverse events (<3.6%), arrhythmias and heart block (0.3% to 3.8%), and pulmonary artery rupture (0.02% to 0.03%).
Transthoracic echocardiography
TTE is a non-invasive ultrasound-based diagnostic tool that has the ability to also evaluate and track both RV and LV hemodynamic status. There is conflicting evidence of the utility of TTE monitoring in reflecting the hemodynamic changes in PAC-derived hemodynamic measurements.
Lung Ultrasound (LUS)
LUS allows for a rapid point-of-care evaluation of a number of conditions, including pulmonary edema, lung consolidation, pleural effusion, and pneumothorax. High intra-rater and inter-rater reproducibility, ease of learning, short exam duration (<5 min), and the noninvasive nature of this technique makes it an advantageous point-of-care tool. LUS is increasingly used in the acute care setting, and has improved diagnostic accuracy compared with clinical assessment and chest radiography for the identification of a cardiac aetiology in patients presenting to the emergency department with undifferentiated dyspnea. Quantification of B-lines (vertical artefacts that result from an increase in interstitial density) has been shown to be useful for the diagnosis, monitoring, and risk assessment of patients with known or suspected ADHF. Either curvilinear or phased array transducers can be used, typically at an imaging depth of 14-18 cm.
Hypothesis
The investigators hypothesize that non-invasive hemodynamic parameters derived from TTE would be comparable to those obtained invasively by PAC in patient admitted to the CICU. The investigators also hypothesize that there will be a strong correlation between intracardiac pressures and the severity of pulmonary congestion as evaluated by LUS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to CICU | – | Diagnostic Test: Echocardiography and lung ultrasoundThe study population will be composed of patients admitted to the Coronary Intensive Care Unit (CICU) requiring hemodynamic assessment using pulmonary artery catheter (PAC) as standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of patients admitted to the Coronary Intensive Care Unit (CICU) requiring hemodynamic assessment using pulmonary artery catheter (PAC) as standard of care.
Key inclusion criteria (1 listed)
- Patients with admitted to the CICU in whom PAC is inserted as standard of care,
Key exclusion criteria (1 listed)
- Enrollment into another trial with an active treatment arm
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 |
|---|---|---|
| Echocardiography and lung ultrasoundAll patients will undergo non-invasive echocardiogram and lung ultrasound at times of assessment of hemodynamic parameters as needed by usual clinical management. | Diagnostic test | Patients admitted to CICU |
Primary outcome
Correlation between E/e' ratio and PCWP vs. correlation between lung ultrasound score and PCWP.
Time frame: Day 1
To determine whether non-invasive assessment of hemodynamics by echocardiogram are comparable to invasive measurements.
7 secondary outcomes
Correlation between cardiac output measured by echocardiography (using LVOT diameter and VTI) and by PAC (using thermodilution)
Time frame: Day 1, Day 2
Correlation between right atrial pressure assessed by echocardiography (using IVC diameter and respiratory variation) and by PAC
Time frame: Day 1, Day 2
Correlation between pulmonary pressure assessed by echocardiography (using TR max velocity and estimated RAP) and by PAC
Time frame: Day 1, Day 2
Correlation between pulmonary pressure assessed by echocardiography (using PAT) and by PAC
Time frame: Day 1, Day 2
Correlation between PVR assessed by echocardiography (using PAT) and by PAC
Time frame: Day 1, Day 2
Correlation between right ventricular function assessed by echocardiography (using TAPSE and S') and by PAC (using PAPI and RVSWI)
Time frame: Day 1, Day 2
Correlation between E/e' ratio and PCWP vs. correlation between lung ultrasound score and PCWP.
Time frame: Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- 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.
Filio Billia, MD PhD principal investigator
UHN
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 Cardiogenic Shock and Heart Failure, run by University Health Network, Toronto at 1 site in Canada.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Mar 2024. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yishay Szekely, MD (416-340-4800 ext. 6805, Yishay.szekely@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between E/e' ratio and PCWP vs. correlation between lung ultrasound score and PCWP. (time frame: Day 1). 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 Mar 2024.