Cardiogenic ShockHEARTNCT07163052
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
An observational study of Cardiogenic Shock and Pulmonary Edema Cardiac Cause, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial summary
Accurate hemodynamic monitoring is critical in cardiothoracic surgery, where left atrial pressure (LAP) serves as the gold standard for assessing left-sided cardiac filling pressures. However, its invasive nature limits use, favoring pulmonary capillary wedge pressure (PCWP) via Swan-Ganz catheter as a surrogate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Pulmonary Edema Cardiac Cause
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients undergoing elective cardiac surgery for aortic valve regurgitation, mitral valve, coronary or aortic disease. We aim to include patients without significant impairment in cardiac function. Nonetheless, there are inherent primary and secondary effects of cardiac pathology leading to structural disease. The procedures, as noted in the inclusion criteria (4.2), are standard procedures in our hospital and are regularly performed. We want to select the patient from our wait list. No extra measures are taken to include the patients.
Who may be able to join
- the primary procedure is cardiac surgery by median sternotomy
- the use of CPB
- patients undergoing aortic valve replacement (AVR) due to aortic regurgitation, mitral valve plasty (MVP), mitral valve repair (MVR), valve sparing aortic root replacement or supracoronary aorta ascendens replacement (SCAR)
- left ventricular ejection fraction of 60% or more
- no clinical or echocardiographic signs of preoperative decompensation cordis
- only elective procedures
Who cannot join
- patients with left ventricular hypertrophy (LVH), severe aortic stenosis or hypertrophic obstructive cardiomyopathy. LVH is defined as an increased LVMI greater than 95 grams per square meter (g/m²) in women and greater than 115 g/m² in men.
- patients with echocardiographically observed RV or LV dilatation are assessed using specific criteria. For RV dilatation, a TAPSE of less than 14 millimeters or an RV FAC of less than 35% is indicative of dilatation. For LV dilatation, an LV end-diastolic (LVED) diameter greater than 2.7 centimeters per square meter or exceeding 117% of the predicted value, adjusted for age and body surface area, is considered dilated.
- patients undergoing more than one type of procedure (i.e. double valve surgery, CABG and AVR)
- postoperative aortic valve mean pressure gradient of more than 20 mm Hg and mitral valve mean pressure gradient of more than 5 mm Hg
- postoperative paravalvular leak grade 2 or more
- postoperative persistent regional wall abnormalities or electrocardiographic signs of acute ischemia
- other significant valve pathology, such as moderate mitral regurgitation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Accurate hemodynamic monitoring is critical in cardiothoracic surgery, where left atrial pressure (LAP) serves as the gold standard for assessing left-sided cardiac filling pressures. However, its invasive nature limits use, favoring pulmonary capillary wedge pressure (PCWP) via Swan-Ganz catheter as a surrogate. Despite widespread use, evidence on their agreement under dynamic conditions-such as varying cardiac index (CI) flows during cardiopulmonary bypass (CPB) or left ventricular (LV) unloading-remains inconsistent and unstudied in adult cardiac surgery.
Existing data show conflicting correlations: one study found that PCWP 35% higher than LAP in non-surgical patients, and another study found closer alignment in specific cohorts. This knowledge gap carries clinical urgency, as decisions on pulmonary edema management, vasopressor use, and LV decompression rely on these measurements.
Read more
Building on Laplace's law, we hypothesize that LV unloading reduces ventricular wall stress (afterload), lowering myocardial oxygen demand and altering the LAP-PCWP relationship. Elevated CI during CPB may further distort this interaction via increased pulmonary-left atrial pressure gradients.
The primary objective is to determine if PCWP reliably reflects LAP under standard CI-flow (2.4 L/min/m²) without unloading, using Bland-Altman analysis (±5 mmHg clinical margin). Secondary objectives assess agreement at other CI levels (1.8-2.6 L/min/m²), LV unloading effects, and patient/surgical variable impacts.
Read the detailed description
Effective hemodynamic monitoring is essential for optimizing postoperative management in cardiothoracic surgery. Left atrial pressure (LAP) is considered the gold standard for assessing left-sided cardiac filling pressures, but is typically measured directly only in selected cases due to its invasive nature. Pulmonary capillary wedge pressure (PCWP), measured via a Swan-Ganz catheter, is widely used as a less invasive surrogate for LAP. However, evidence suggests that the agreement between PCWP and directly measured LAP may vary under different hemodynamic conditions, particularly at higher cardiac index (CI) flow rates and with or without left ventricular (LV) unloading. To date, no in-vivo study has systematically quantified the agreement between these two methods in adult patients during cardiopulmonary bypass (CPB) at varying flow rates and unloading conditions.
Existing studies report inconsistent correlations between LAP and PCWP. For example, one study observed PCWP values 35% higher than LAP in non-surgical patients, while another study noted tighter correlations in specific cohorts. However, no in-vivo data exist for adult cardiac surgery patients under controlled CI-flow rates (+/- LV unloading). This gap is clinically critical, as decisions regarding pulmonary edema management, vasopressor use, and LV decompression rely on these measurements.
Building on Laplace's law, we hypothesize that LV unloading reduces ventricular wall stress (afterload), thereby lowering myocardial oxygen demand and improving recovery. Computational models and animal studies suggest that unloading decreases LV end-diastolic pressure (LVEDP) and left atrial (LA) volume, which may alter the LAP-PCWP relationship. Elevated CI during CPB could further modulate this interaction, as increased flow rates may exacerbate pressure gradients between the pulmonary vasculature and left atrium.
The primary objective of our study is therefore to determine whether PCWP can be considered an adequate surrogate for directly measured LAP under standard CI-flow (2.4 L/min/m²) without LV unloading, using a Bland-Altman analysis. Secondary objectives include evaluating the agreement between LAP and PCWP at other CI-flow rates and with LV unloading, as well as exploring the influence of patient characteristics and surgical variables. By addressing these questions, we hope to provide evidence to guide the interpretation of PCWP in clinical practice, potentially improving the safety and outcomes of patients undergoing cardiac surgery.
- Conditions
- Cardiogenic Shock, Pulmonary Edema Cardiac Cause
- Keywords
- LV unloading, post-cardiotomy shock, PCS, filling pressures
- Medical subject headings
- Shock, Cardiogenic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total cohort | Patients with and without LV unloading under different cardiac indeces via cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between left atrial pressure (LAP) and pulmonary capillary wedge pressure (PCWP) under standard cardiac index (CI) conditions.
The primary outcome is the mean absolute difference between LAP and PCWP, quantified using Bland-Altman analysis. PCWP will be considered an adequate surrogate for LAP if the 95% limits of agreement fall within ±5 mmHg.
Independent: cardiac index fixed at 2.4 L/min/m² without LV unloading Dependent: difference between LAP and PCWP (mmHg)
Measured: Intraoperatively
Secondary outcomes (11)
Effect of different cardiac index (CI) flow rates and LV unloading on agreement between left atrial pressure (LAP) and pulmonary capillary wedge pressure (PCWP)
Agreement between LAP and PCWP will be assessed for each CI flow rate and LV unloading condition using Bland-Altman analysis (95% limits of agreement). Correlation between LAP and PCWP will also be calculated (Pearson or Spearman) (mmHg)
Measured: Intraoperatively
Pre- and postoperative changes in left atrial pressure (LAP) and pulmonary capillary wedge pressure (PCWP) in mitral valve patients
Comparison of LAP and PCWP before and after mitral valve surgery. Statistical analysis will be performed using paired t-test or Wilcoxon Signed-Rank test, depending on data distribution (mmHg).
Measured: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: LVEDV
Echocardiographic chamber volumes (LVEDV) will be summarized (mean ± SD or median [IQR]) and associated with LAP/PCWP. Used for pressure-volume loop construction with invasive pressures.
mL
Measured: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: LV wall thickness
LV hypertrophy will be recorded and associated with LAP/PCWP.
mm
Measured: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: LVEF
Functional measures of LV and RV performance, diastolic filling pressures, and mitral regurgitation severity will be summarized and associated with LAP/PCWP.
LVEF: %
Measured: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: E/e'
Functional measures of leftsided diastolic filling pressures will be summarized and associated with LAP/PCWP.
E/e' ratio: unitless
Measured: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: TAPSE
Functional measures of RV performance will be summarized and associated with LAP/PCWP.
TAPSE: mm
Measured: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: mitral regurgitation grade
Functional measures of mitral regurgitation severity will be summarized and associated with LAP/PCWP.
Mitral regurgitation: ordinal grade (1-4)
Measured: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: LAVI
Echocardiographic chamber volumes (LAVI) will be summarized (mean ± SD or median [IQR]) and associated with LAP/PCWP. Used for pressure-volume loop construction with invasive pressures.
mL/m²
Measured: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: RAVI
Echocardiographic chamber volumes (RAVI) will be summarized (mean ± SD or median [IQR]) and associated with LAP/PCWP. Used for pressure-volume loop construction with invasive pressures.
mL/m²
Measured: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: LVOT dimensions
LVOT dimensions will be recorded and associated with LAP/PCWP.
mm
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Oct 2026 (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.
- 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
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ufuk Baldan, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163052
- Sponsor's protocol ID
- HEART
- Acronym
- HEART
- Status last verified
- Sep 2025
- First submitted
- 24 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
- ClinicalTrials.gov ID
- NCT07163052
- Acronym / sponsor ID
- HEART / HEART
- Conditions
- Cardiogenic Shock, Pulmonary Edema Cardiac Cause
- Keywords
- LV unloading, post-cardiotomy shock, PCS, filling pressures
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 9 Sep 2025 (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.
Accurate hemodynamic monitoring is critical in cardiothoracic surgery, where left atrial pressure (LAP) serves as the gold standard for assessing left-sided cardiac filling pressures. However, its invasive nature limits use, favoring pulmonary capillary wedge pressure (PCWP) via Swan-Ganz catheter as a surrogate. Despite widespread use, evidence on their agreement under dynamic conditions-such as varying cardiac index (CI) flows during cardiopulmonary bypass (CPB) or left ventricular (LV) unloading-remains inconsistent and unstudied in adult cardiac surgery.
Existing data show conflicting correlations: one study found that PCWP 35% higher than LAP in non-surgical patients, and another study found closer alignment in specific cohorts. This knowledge gap carries clinical urgency, as decisions on pulmonary edema management, vasopressor use, and LV decompression rely on these measurements.
Building on Laplace's law, we hypothesize that LV unloading reduces ventricular wall stress (afterload), lowering myocardial oxygen demand and altering the LAP-PCWP relationship. Elevated CI during CPB may further distort this interaction via increased pulmonary-left atrial pressure gradients.
The primary objective is to determine if PCWP reliably reflects LAP under standard CI-flow (2.4 L/min/m²) without unloading, using Bland-Altman analysis (±5 mmHg clinical margin). Secondary objectives assess agreement at other CI levels (1.8-2.6 L/min/m²), LV unloading effects, and patient/surgical variable impacts.
Detailed description
Effective hemodynamic monitoring is essential for optimizing postoperative management in cardiothoracic surgery. Left atrial pressure (LAP) is considered the gold standard for assessing left-sided cardiac filling pressures, but is typically measured directly only in selected cases due to its invasive nature. Pulmonary capillary wedge pressure (PCWP), measured via a Swan-Ganz catheter, is widely used as a less invasive surrogate for LAP. However, evidence suggests that the agreement between PCWP and directly measured LAP may vary under different hemodynamic conditions, particularly at higher cardiac index (CI) flow rates and with or without left ventricular (LV) unloading. To date, no in-vivo study has systematically quantified the agreement between these two methods in adult patients during cardiopulmonary bypass (CPB) at varying flow rates and unloading conditions.
Existing studies report inconsistent correlations between LAP and PCWP. For example, one study observed PCWP values 35% higher than LAP in non-surgical patients, while another study noted tighter correlations in specific cohorts. However, no in-vivo data exist for adult cardiac surgery patients under controlled CI-flow rates (+/- LV unloading). This gap is clinically critical, as decisions regarding pulmonary edema management, vasopressor use, and LV decompression rely on these measurements.
Building on Laplace's law, we hypothesize that LV unloading reduces ventricular wall stress (afterload), thereby lowering myocardial oxygen demand and improving recovery. Computational models and animal studies suggest that unloading decreases LV end-diastolic pressure (LVEDP) and left atrial (LA) volume, which may alter the LAP-PCWP relationship. Elevated CI during CPB could further modulate this interaction, as increased flow rates may exacerbate pressure gradients between the pulmonary vasculature and left atrium.
The primary objective of our study is therefore to determine whether PCWP can be considered an adequate surrogate for directly measured LAP under standard CI-flow (2.4 L/min/m²) without LV unloading, using a Bland-Altman analysis. Secondary objectives include evaluating the agreement between LAP and PCWP at other CI-flow rates and with LV unloading, as well as exploring the influence of patient characteristics and surgical variables. By addressing these questions, we hope to provide evidence to guide the interpretation of PCWP in clinical practice, potentially improving the safety and outcomes of patients undergoing cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total cohort | – | –Patients with and without LV unloading under different cardiac indeces via cardiopulmonary bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective cardiac surgery for aortic valve regurgitation, mitral valve, coronary or aortic disease. We aim to include patients without significant impairment in cardiac function. Nonetheless, there are inherent primary and secondary effects of cardiac pathology leading to structural disease. The procedures, as noted in the inclusion criteria (4.2), are standard procedures in our hospital and are regularly performed. We want to select the patient from our wait list. No extra measures are taken to include the patients.
Key inclusion criteria (6 listed)
- the primary procedure is cardiac surgery by median sternotomy
- the use of CPB
- patients undergoing aortic valve replacement (AVR) due to aortic regurgitation, mitral valve plasty (MVP), mitral valve repair (MVR), valve sparing aortic root replacement or supracoronary aorta ascendens replacement (SCAR)
- left ventricular ejection fraction of 60% or more
- no clinical or echocardiographic signs of preoperative decompensation cordis
Key exclusion criteria (7 listed)
- patients with left ventricular hypertrophy (LVH), severe aortic stenosis or hypertrophic obstructive cardiomyopathy. LVH is defined as an increased LVMI greater than 95 grams per square meter (g/m²) in women and greater than 115 g/m² in men.
- patients with echocardiographically observed RV or LV dilatation are assessed using specific criteria. For RV dilatation, a TAPSE of less than 14 millimeters or an RV FAC of less than 35% is indicative of dilatation. For LV dilatation, an LV end-diastolic (LVED) diameter greater than 2.7 centimeters per square meter or exceeding 117% of the predicted value, adjusted for age and body surface area, is considered dilated.
- patients undergoing more than one type of procedure (i.e. double valve surgery, CABG and AVR)
- postoperative aortic valve mean pressure gradient of more than 20 mm Hg and mitral valve mean pressure gradient of more than 5 mm Hg
- postoperative paravalvular leak grade 2 or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement between left atrial pressure (LAP) and pulmonary capillary wedge pressure (PCWP) under standard cardiac index (CI) conditions.
Time frame: Intraoperatively
The primary outcome is the mean absolute difference between LAP and PCWP, quantified using Bland-Altman analysis. PCWP will be considered an adequate surrogate for LAP if the 95% limits of agreement fall within ±5 mmHg. Independent: cardiac index fixed at 2.4 L/min/m² without LV unloading Dependent: difference between LAP and PCWP (mmHg)
11 secondary outcomes
Effect of different cardiac index (CI) flow rates and LV unloading on agreement between left atrial pressure (LAP) and pulmonary capillary wedge pressure (PCWP)
Time frame: Intraoperatively
Pre- and postoperative changes in left atrial pressure (LAP) and pulmonary capillary wedge pressure (PCWP) in mitral valve patients
Time frame: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: LVEDV
Time frame: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: LV wall thickness
Time frame: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: LVEF
Time frame: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: E/e'
Time frame: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: TAPSE
Time frame: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: mitral regurgitation grade
Time frame: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: LAVI
Time frame: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: RAVI
Time frame: Intraoperatively
Association between echocardiographic parameters and invasive pressure measurements: LVOT dimensions
Time frame: Intraoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Pulmonary Edema Cardiac Cause, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact B U Baldan, MD (020 566 9111, b.u.baldan@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between left atrial pressure (LAP) and pulmonary capillary wedge pressure (PCWP) under standard cardiac index (CI) conditions. (time frame: Intraoperatively). 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 9 Sep 2025.