Heart DiseaseSHAPENCT07770269
Assessment of Cardiac Function and Anesthesia Depth in Patients Undergoing Cardiac Surgery
A study testing BIS-guided anesthesia: BIS 45-55 and BIS-guided anesthesia: BIS 30-35 in people with Heart Disease, run by AHEPA University Hospital at 1 site in Greece.
Trial summary
The SHAPE study is a prospective, randomized study evaluating changes in cardiac function in adult patients undergoing cardiac surgery with cardiopulmonary bypass. The study focuses on how cardiac function changes during surgery and whether the depth of anesthesia may influence these changes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease
- What is being tested?
- BIS-guided anesthesia: BIS 45-55 and BIS-guided anesthesia: BIS 30-35
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- 19 Jan 2026to Nov 2027
- Phase
- Interventional
- 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
Who may be able to join
- Adults aged 18 years or older, irrespective of sex.
- Scheduled to undergo elective cardiac surgery involving cardiopulmonary bypass (on-pump surgery).
- Anticipated adequate acoustic window for transthoracic echocardiography.
- Provision of written informed consent.
Who cannot join
- - Emergency or unscheduled cardiac surgery.
- Cardiac surgery without cardiopulmonary bypass (off-pump surgery).
- Refusal or inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 54636
Christos Mantzios, Cardiology Resident, MD, MSc, +306983282188, chrismantzios1994@gmail.com
chrismantzios1994@gmail.com
About this study
Official title: Multifactorial Assessment of Cardiac Function Through Deformation Imaging, Hemodynamic Parameters, and Anesthesia-related Variables in Patients Undergoing Cardiac Surgery: The SHAPE Study
The SHAPE study is a prospective, randomized study evaluating changes in cardiac function in adult patients undergoing cardiac surgery with cardiopulmonary bypass. The study focuses on how cardiac function changes during surgery and whether the depth of anesthesia may influence these changes.
Participants are randomly assigned to one of two levels of anesthesia depth, guided by the Bispectral Index (BIS). Cardiac function is assessed using transthoracic echocardiography, including myocardial deformation (strain) imaging and myocardial work measurements. Invasive hemodynamic measurements obtained during surgery are also recorded.
Read more
The primary objective is to assess the change in left ventricular global longitudinal strain (LV GLS) between two intraoperative time points: after induction of anesthesia and before cardiopulmonary bypass, and after separation from cardiopulmonary bypass. The study will also examine whether these changes differ according to the assigned depth of anesthesia and whether echocardiographic and hemodynamic measurements are associated with postoperative outcomes.
Participants will also undergo follow-up echocardiographic assessment at 3, 6, and 12 months after surgery to evaluate longer-term changes in cardiac function.
Read the detailed description
The SHAPE study is a prospective, randomized, parallel-group, single-masked interventional study conducted in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. The study is designed to investigate perioperative changes in myocardial function and to assess the potential influence of anesthesia depth on these changes.
Participants are randomized in a 1:1 ratio to two Bispectral Index (BIS)-guided anesthesia strategies: a BIS target of 45-55, representing standard anesthesia depth, or a BIS target of 30-35, representing deeper anesthesia. Total intravenous anesthesia with propofol and remifentanil is adjusted by the treating anesthesiologist to maintain the assigned BIS range. The echocardiographic outcome assessor remains blinded to treatment allocation during image acquisition, offline echocardiographic analysis, and primary outcome assessment.
Cardiac function is evaluated using transthoracic echocardiography and speckle-tracking analysis. Measurements include left ventricular global longitudinal strain (LV GLS), myocardial work indices, and additional indices of left- and right-sided cardiac function. Invasive hemodynamic monitoring using a Swan-Ganz catheter provides measurements including pulmonary capillary wedge pressure, cardiac output, cardiac index, pulmonary artery pressure, and right atrial pressure.
The primary analysis evaluates the within-participant change in LV GLS between two predefined intraoperative time points: after induction of anesthesia and before initiation of cardiopulmonary bypass (T1), and after separation from cardiopulmonary bypass (T2). Secondary analyses will assess whether the magnitude of perioperative changes in LV GLS and myocardial work differs between the two randomized BIS groups and will explore associations between echocardiographic measurements, invasive hemodynamic parameters, and postoperative clinical outcomes.
Postoperative outcomes include low cardiac output syndrome, requirement for inotropic or vasopressor support, postoperative atrial fibrillation, duration of mechanical ventilation, and length of intensive care unit stay. Echocardiographic follow-up is performed at 3, 6, and 12 months after surgery to assess longer-term changes in cardiac function.
- Conditions
- Heart Disease
- Being tested
- BIS-guided anesthesia: BIS 45-55, BIS-guided anesthesia: BIS 30-35
- Keywords
- Cardiac Surgery, Cardiopulmonary Bypass, Global Longitudinal Strain, Myocardial Work, Speckle-Tracking Echocardiography, Bispectral Index, Depth of Anesthesia, Hemodynamic Monitoring, Swan-Ganz Catheter, Low Cardiac Output Syndrome
- Medical subject headings
- Heart Diseases, Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS-guided anesthesia: BIS 45-55Other
Total intravenous anesthesia with propofol and remifentanil will be adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 45-55, representing standard anesthesia depth.
BIS-guided anesthesia: BIS 30-35Other
Total intravenous anesthesia with propofol and remifentanil will be adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 30-35, representing deeper anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| BIS 45-55 | Active comparator | Participants assigned to this arm will receive total intravenous anesthesia with propofol and remifentanil, adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 45-55, representing standard anesthesia depth. Receives: Other: BIS-guided anesthesia: BIS 45-55 |
| BIS 30-35 | Experimental | Participants assigned to this arm will receive total intravenous anesthesia with propofol and remifentanil, adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 30-35, representing deeper anesthesia. Receives: Other: BIS-guided anesthesia: BIS 30-35 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-Participant Change in Left Ventricular Global Longitudinal Strain (LV GLS) From T1 to T2
Left ventricular global longitudinal strain (LV GLS) will be assessed by speckle-tracking echocardiography at two predefined intraoperative time points: T1, after induction of anesthesia and before initiation of cardiopulmonary bypass, and T2, after separation from cardiopulmonary bypass. The primary outcome will be the within-participant change in LV GLS, calculated as T2 minus T1 and expressed in percentage points. Because LV GLS is expressed as a negative value, a positive T2-minus-T1 difference indicates a reduction in the absolute magnitude of LV GLS and therefore deterioration in longitudinal systolic function.
Measured: During index cardiac surgery: T1 after induction of anesthesia and before cardiopulmonary bypass; T2 after separation from cardiopulmonary bypass.
Secondary outcomes (27)
Change in Left Ventricular Global Longitudinal Strain (LV GLS) From T1 to T2 by Randomized BIS Group
Left ventricular global longitudinal strain (LV GLS) will be assessed by speckle-tracking echocardiography at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. The within-participant change in LV GLS (T2 minus T1), expressed in percentage points, will be compared between participants randomized to the BIS 45-55 and BIS 30-35 groups.
Measured: During index cardiac surgery: from T1 before cardiopulmonary bypass to T2 after separation from cardiopulmonary bypass.
Change in Left Ventricular Myocardial Work Indices From T1 to T2 by Randomized BIS Group
Left ventricular myocardial work will be assessed using non-invasive pressure-strain loops at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. Myocardial work indices will include Global Work Index (GWI), Global Constructive Work (GCW), Global Wasted Work (GWW), and Global Work Efficiency (GWE). Changes from T1 to T2 will be assessed within participants and compared between the BIS 45-55 and BIS 30-35 groups.
Measured: During index cardiac surgery: from T1, before cardiopulmonary bypass, to T2, after separation from cardiopulmonary bypass.
Postoperative Adverse Clinical Events
Postoperative adverse clinical events will include the occurrence of low cardiac output syndrome (LCOS), requirement for inotropic or vasopressor support, and postoperative atrial fibrillation (POAF). Each event will be recorded during the postoperative hospitalization and evaluated in relation to perioperative echocardiographic, hemodynamic, and anesthesia-related parameters.
Measured: From completion of index cardiac surgery through discharge during the index hospitalization, assessed up to 60 days after surgery.
Duration of Mechanical Ventilation
The duration of postoperative mechanical ventilation will be recorded as the time from completion of index cardiac surgery until successful extubation. Duration will be expressed in minutes and analyzed in relation to perioperative echocardiographic, hemodynamic, and anesthesia-related parameters.
Measured: From completion of index cardiac surgery until successful extubation during the index hospitalization, assessed up to 60 days after surgery.
Length of Intensive Care Unit Stay
The length of stay in the intensive care unit (ICU) will be recorded as the duration from postoperative admission to the ICU until discharge from the ICU. Duration will be expressed in days and analyzed in relation to perioperative echocardiographic, hemodynamic, and anesthesia-related parameters.
Measured: From postoperative ICU admission until ICU discharge during the index hospitalization, assessed up to 60 days after surgery.
Change in Left Ventricular Global Longitudinal Strain During Follow-up
Left ventricular global longitudinal strain (LV GLS) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). LV GLS will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Measured: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Left Ventricular Global Work Index During Follow-up
Left ventricular Global Work Index (GWI) will be assessed using non-invasive pressure-strain loop analysis and expressed in mmHg%. GWI will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Measured: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Left Ventricular Global Constructive Work During Follow-up
Left ventricular Global Constructive Work (GCW) will be assessed using non-invasive pressure-strain loop analysis and expressed in mmHg%. GCW will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Measured: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Left Ventricular Global Wasted Work During Follow-up
Left ventricular Global Wasted Work (GWW) will be assessed using non-invasive pressure-strain loop analysis and expressed in mmHg%. GWW will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Measured: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Left Ventricular Global Work Efficiency During Follow-up
Left ventricular Global Work Efficiency (GWE) will be assessed using non-invasive pressure-strain loop analysis and expressed as a percentage (%). GWE will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Measured: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Right Ventricular Free-Wall Strain During Follow-up
Right ventricular free-wall strain (RV FWS) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). RV FWS will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Measured: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Right Atrial Strain During Follow-up
Right atrial strain (RA strain) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). RA strain will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Measured: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Tricuspid Annular Plane Systolic Excursion During Follow-up
Tricuspid annular plane systolic excursion (TAPSE) will be assessed by transthoracic echocardiography and expressed in millimeters (mm). TAPSE will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Measured: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Presence of Paradoxical Septal Motion During Follow-up
Interventricular septal motion will be assessed by transthoracic echocardiography and classified according to the presence or absence of paradoxical septal motion (PSM). PSM status will be recorded preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery to evaluate its postoperative evolution.
Measured: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in TAPSE/sPAP Ratio During Follow-up
The ratio of tricuspid annular plane systolic excursion to systolic pulmonary artery pressure (TAPSE/sPAP), an echocardiographic index of right ventricular-pulmonary arterial coupling, will be assessed by transthoracic echocardiography and expressed in mm/mmHg. The TAPSE/sPAP ratio will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Measured: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Correlation Between Left Ventricular Global Longitudinal Strain and Pulmonary Capillary Wedge Pressure
Left ventricular global longitudinal strain (LV GLS) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter and expressed in mmHg. Both measurements will be obtained at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. The correlation between LV GLS and PCWP will be assessed at each time point using Pearson's or Spearman's correlation coefficient, as appropriate.
Measured: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Left Ventricular Global Work Index and Pulmonary Capillary Wedge Pressure
Left ventricular Global Work Index (GWI) will be assessed using non-invasive pressure-strain loop analysis and expressed in mmHg%. Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter and expressed in mmHg. Both measurements will be obtained at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. The correlation between GWI and PCWP will be assessed at each time point using Pearson's or Spearman's correlation coefficient, as appropriate.
Measured: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Left Ventricular Global Constructive Work and Pulmonary Capillary Wedge Pressure
Left ventricular Global Constructive Work (GCW) will be assessed using non-invasive pressure-strain loop analysis and expressed in mmHg%. Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter and expressed in mmHg. Both measurements will be obtained at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. The correlation between GCW and PCWP will be assessed at each time point using Pearson's or Spearman's correlation coefficient, as appropriate.
Measured: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Left Ventricular Global Wasted Work and Pulmonary Capillary Wedge Pressure
Left ventricular Global Wasted Work (GWW) will be assessed using non-invasive pressure-strain loop analysis and expressed in mmHg%. Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter and expressed in mmHg. Both measurements will be obtained at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. The correlation between GWW and PCWP will be assessed at each time point using Pearson's or Spearman's correlation coefficient, as appropriate.
Measured: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Left Ventricular Global Work Efficiency and Pulmonary Capillary Wedge Pressure
Left ventricular Global Work Efficiency (GWE) will be assessed using non-invasive pressure-strain loop analysis and expressed as a percentage (%). Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter and expressed in mmHg. Both measurements will be obtained at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. The correlation between GWE and PCWP will be assessed at each time point using Pearson's or Spearman's correlation coefficient, as appropriate.
Measured: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Preoperative Right Atrial Strain and Intraoperative Pulmonary Capillary Wedge Pressure
Preoperative right atrial strain (RA strain) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter at T1 and expressed in mmHg. The correlation between preoperative RA strain and PCWP will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate.
Measured: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative Right Atrial Strain and Intraoperative Cardiac Index
Preoperative right atrial strain (RA strain) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). Cardiac index (CI) will be measured invasively using a Swan-Ganz catheter at T1 and expressed in L/min/m². The correlation between preoperative RA strain and CI will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate.
Measured: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative cardiac index assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative Right Ventricular Free-Wall Strain and Intraoperative Pulmonary Capillary Wedge Pressure
Preoperative right ventricular free-wall strain (RV FWS) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter at T1 and expressed in mmHg. The correlation between preoperative RV FWS and PCWP will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate.
Measured: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative Right Ventricular Free-Wall Strain and Intraoperative Cardiac Index
Preoperative right ventricular free-wall strain (RV FWS) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). Cardiac index (CI) will be measured invasively using a Swan-Ganz catheter at T1 and expressed in L/min/m². The correlation between preoperative RV FWS and CI will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate.
Measured: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative cardiac index assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative TAPSE/sPAP Ratio and Intraoperative Pulmonary Capillary Wedge Pressure
The preoperative TAPSE/sPAP ratio will be assessed by transthoracic echocardiography and expressed in mm/mmHg. Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter at T1 and expressed in mmHg. The correlation between the preoperative TAPSE/sPAP ratio and PCWP will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate.
Measured: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative TAPSE/sPAP Ratio and Intraoperative Cardiac Index
The preoperative TAPSE/sPAP ratio will be assessed by transthoracic echocardiography and expressed in mm/mmHg. Cardiac index (CI) will be measured invasively using a Swan-Ganz catheter at T1 and expressed in L/min/m². The correlation between the preoperative TAPSE/sPAP ratio and CI will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate.
Measured: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative cardiac index assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative E/LA Strain Ratio and Intraoperative Pulmonary Capillary Wedge Pressure
The preoperative E/LA strain ratio will be calculated as the ratio of early diastolic transmitral flow velocity (E), measured by pulsed-wave Doppler echocardiography and expressed in cm/s, to left atrial strain, measured by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). The E/LA strain ratio will be expressed in cm/s/%. Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter at T1 and expressed in mmHg. The correlation between the preoperative E/LA strain ratio and intraoperative PCWP will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate.
Measured: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start19 Jan 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christos Mantzios, AHEPA University Hospital
- Investigators
- Vasileios Kamperidis, Assistant Professor, Study chair, 1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, GreeceDespoina Sarridou, Associate Professor, Study director, Department of Anesthesiology, AHEPA University Hospital, Aristotle University of ThessalonikiHelena Argiriadou, Professor, Study director, Department of Anesthesiology and Intensive Care, AHEPA University Hospital, Aristotle University of ThessalonikiAntonios Ziakas, Professor, Study director, 1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, GreeceChristos Mantzios, Cardiology Resident, MD, MSc, Principal investigator, 1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770269
- Sponsor's protocol ID
- SHAPE
- Acronym
- SHAPE
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactorial Assessment of Cardiac Function Through Deformation Imaging, Hemodynamic Parameters, and Anesthesia-related Variables in Patients Undergoing Cardiac Surgery: The SHAPE Study
- ClinicalTrials.gov ID
- NCT07770269
- Acronym / sponsor ID
- SHAPE / SHAPE
- Conditions
- Heart Disease
- Keywords
- Cardiac Surgery, Cardiopulmonary Bypass, Global Longitudinal Strain, Myocardial Work, Speckle-Tracking Echocardiography, Bispectral Index, Depth of Anesthesia, Hemodynamic Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Aug 2026 (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.
The SHAPE study is a prospective, randomized study evaluating changes in cardiac function in adult patients undergoing cardiac surgery with cardiopulmonary bypass. The study focuses on how cardiac function changes during surgery and whether the depth of anesthesia may influence these changes.
Participants are randomly assigned to one of two levels of anesthesia depth, guided by the Bispectral Index (BIS). Cardiac function is assessed using transthoracic echocardiography, including myocardial deformation (strain) imaging and myocardial work measurements. Invasive hemodynamic measurements obtained during surgery are also recorded.
The primary objective is to assess the change in left ventricular global longitudinal strain (LV GLS) between two intraoperative time points: after induction of anesthesia and before cardiopulmonary bypass, and after separation from cardiopulmonary bypass. The study will also examine whether these changes differ according to the assigned depth of anesthesia and whether echocardiographic and hemodynamic measurements are associated with postoperative outcomes.
Participants will also undergo follow-up echocardiographic assessment at 3, 6, and 12 months after surgery to evaluate longer-term changes in cardiac function.
Detailed description
The SHAPE study is a prospective, randomized, parallel-group, single-masked interventional study conducted in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. The study is designed to investigate perioperative changes in myocardial function and to assess the potential influence of anesthesia depth on these changes.
Participants are randomized in a 1:1 ratio to two Bispectral Index (BIS)-guided anesthesia strategies: a BIS target of 45-55, representing standard anesthesia depth, or a BIS target of 30-35, representing deeper anesthesia. Total intravenous anesthesia with propofol and remifentanil is adjusted by the treating anesthesiologist to maintain the assigned BIS range. The echocardiographic outcome assessor remains blinded to treatment allocation during image acquisition, offline echocardiographic analysis, and primary outcome assessment.
Cardiac function is evaluated using transthoracic echocardiography and speckle-tracking analysis. Measurements include left ventricular global longitudinal strain (LV GLS), myocardial work indices, and additional indices of left- and right-sided cardiac function. Invasive hemodynamic monitoring using a Swan-Ganz catheter provides measurements including pulmonary capillary wedge pressure, cardiac output, cardiac index, pulmonary artery pressure, and right atrial pressure.
The primary analysis evaluates the within-participant change in LV GLS between two predefined intraoperative time points: after induction of anesthesia and before initiation of cardiopulmonary bypass (T1), and after separation from cardiopulmonary bypass (T2). Secondary analyses will assess whether the magnitude of perioperative changes in LV GLS and myocardial work differs between the two randomized BIS groups and will explore associations between echocardiographic measurements, invasive hemodynamic parameters, and postoperative clinical outcomes.
Postoperative outcomes include low cardiac output syndrome, requirement for inotropic or vasopressor support, postoperative atrial fibrillation, duration of mechanical ventilation, and length of intensive care unit stay. Echocardiographic follow-up is performed at 3, 6, and 12 months after surgery to assess longer-term changes in cardiac function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIS 45-55 | Active comparator | Other: BIS-guided anesthesia: BIS 45-55Participants assigned to this arm will receive total intravenous anesthesia with propofol and remifentanil, adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 45-55, representing standard anesthesia depth. |
| BIS 30-35 | Experimental | Other: BIS-guided anesthesia: BIS 30-35Participants assigned to this arm will receive total intravenous anesthesia with propofol and remifentanil, adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 30-35, representing deeper anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older, irrespective of sex.
- Scheduled to undergo elective cardiac surgery involving cardiopulmonary bypass (on-pump surgery).
- Anticipated adequate acoustic window for transthoracic echocardiography.
- Provision of written informed consent.
Key exclusion criteria (3 listed)
- - Emergency or unscheduled cardiac surgery.
- Cardiac surgery without cardiopulmonary bypass (off-pump surgery).
- Refusal or inability to provide written informed consent.
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 |
|---|---|---|
| BIS-guided anesthesia: BIS 45-55Total intravenous anesthesia with propofol and remifentanil will be adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 45-55, representing standard anesthesia depth. | Other | BIS 45-55 |
| BIS-guided anesthesia: BIS 30-35Total intravenous anesthesia with propofol and remifentanil will be adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 30-35, representing deeper anesthesia. | Other | BIS 30-35 |
Primary outcome
Within-Participant Change in Left Ventricular Global Longitudinal Strain (LV GLS) From T1 to T2
Time frame: During index cardiac surgery: T1 after induction of anesthesia and before cardiopulmonary bypass; T2 after separation from cardiopulmonary bypass.
Left ventricular global longitudinal strain (LV GLS) will be assessed by speckle-tracking echocardiography at two predefined intraoperative time points: T1, after induction of anesthesia and before initiation of cardiopulmonary bypass, and T2, after separation from cardiopulmonary bypass. The primary outcome will be the within-participant change in LV GLS, calculated as T2 minus T1 and expressed in percentage points. Because LV GLS is expressed as a negative value, a positive T2-minus-T1 difference indicates a reduction in the absolute magnitude of LV GLS and therefore deterioration in longitudinal systolic function.
27 secondary outcomes
Change in Left Ventricular Global Longitudinal Strain (LV GLS) From T1 to T2 by Randomized BIS Group
Time frame: During index cardiac surgery: from T1 before cardiopulmonary bypass to T2 after separation from cardiopulmonary bypass.
Change in Left Ventricular Myocardial Work Indices From T1 to T2 by Randomized BIS Group
Time frame: During index cardiac surgery: from T1, before cardiopulmonary bypass, to T2, after separation from cardiopulmonary bypass.
Postoperative Adverse Clinical Events
Time frame: From completion of index cardiac surgery through discharge during the index hospitalization, assessed up to 60 days after surgery.
Duration of Mechanical Ventilation
Time frame: From completion of index cardiac surgery until successful extubation during the index hospitalization, assessed up to 60 days after surgery.
Length of Intensive Care Unit Stay
Time frame: From postoperative ICU admission until ICU discharge during the index hospitalization, assessed up to 60 days after surgery.
Change in Left Ventricular Global Longitudinal Strain During Follow-up
Time frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Left Ventricular Global Work Index During Follow-up
Time frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Left Ventricular Global Constructive Work During Follow-up
Time frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Left Ventricular Global Wasted Work During Follow-up
Time frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Left Ventricular Global Work Efficiency During Follow-up
Time frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Right Ventricular Free-Wall Strain During Follow-up
Time frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Right Atrial Strain During Follow-up
Time frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Tricuspid Annular Plane Systolic Excursion During Follow-up
Time frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Presence of Paradoxical Septal Motion During Follow-up
Time frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in TAPSE/sPAP Ratio During Follow-up
Time frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Correlation Between Left Ventricular Global Longitudinal Strain and Pulmonary Capillary Wedge Pressure
Time frame: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Left Ventricular Global Work Index and Pulmonary Capillary Wedge Pressure
Time frame: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Left Ventricular Global Constructive Work and Pulmonary Capillary Wedge Pressure
Time frame: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Left Ventricular Global Wasted Work and Pulmonary Capillary Wedge Pressure
Time frame: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Left Ventricular Global Work Efficiency and Pulmonary Capillary Wedge Pressure
Time frame: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Preoperative Right Atrial Strain and Intraoperative Pulmonary Capillary Wedge Pressure
Time frame: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative Right Atrial Strain and Intraoperative Cardiac Index
Time frame: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative cardiac index assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative Right Ventricular Free-Wall Strain and Intraoperative Pulmonary Capillary Wedge Pressure
Time frame: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative Right Ventricular Free-Wall Strain and Intraoperative Cardiac Index
Time frame: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative cardiac index assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative TAPSE/sPAP Ratio and Intraoperative Pulmonary Capillary Wedge Pressure
Time frame: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative TAPSE/sPAP Ratio and Intraoperative Cardiac Index
Time frame: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative cardiac index assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative E/LA Strain Ratio and Intraoperative Pulmonary Capillary Wedge Pressure
Time frame: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
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 19 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant-level data will not be shared with other researchers.
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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.
Vasileios Kamperidis, Assistant Professor study chair
1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece
Despoina Sarridou, Associate Professor study director
Department of Anesthesiology, AHEPA University Hospital, Aristotle University of Thessaloniki
Helena Argiriadou, Professor study director
Department of Anesthesiology and Intensive Care, AHEPA University Hospital, Aristotle University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS-guided anesthesia: BIS 45-55 and BIS-guided anesthesia: BIS 30-35 in people with Heart Disease, run by AHEPA University Hospital at 1 site in Greece.
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 4 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. 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 Greece. 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?
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 Christos Mantzios, Cardiology Resident, MD, MSc (+306983282188, chrismantzios1994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-Participant Change in Left Ventricular Global Longitudinal Strain (LV GLS) From T1 to T2 (time frame: During index cardiac surgery: T1 after induction of anesthesia and before cardiopulmonary bypass; T2 after separation from cardiopulmonary bypass.). 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 19 Aug 2026.