Left Sided Heart FailureEDISONNCT05972356
Effect of Left Ventricle Diastolic Dysfunction on Outcomes in Female Cardiac Surgery Patients
An observational study of Left Sided Heart Failure, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The aim of this study is to evaluate the differences between males and females with LVDD, undergoing cardiac surgery. The investigators will look at perioperative factors such as body weight, body surface area, previous medical history, cardiac function measured by amongst others, transoesophageal echocardiography and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Sided Heart Failure
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2025to 1 Sep 2027
- 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 cardiac surgery will be asked for permission to use data collected as standard-of-care
Who may be able to join
- All patients >18 years, who undergo cardiac surgery from 1 January 2023 till 31 December 2026 in the Amsterdam UMC
Who cannot join
- Patients who object to the re-use of their care data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Susanne Eberl, MD,PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center
Amsterdam, North Holland, 1105AZ
Jennifer S Breel, MSc, PhD, +31610019257, j.s.breel@amsterdamumc.nl
Susanne Eberl, MD,PhD, +31610019257, s.eberl@amsterdamumc.nl
About this study
Official title: The Effect of Left Ventricular DIastolic Dysfunction on Short Term Cardiac Surgery Outcomes in Female Cardiac patieNts
The aim of this study is to evaluate the differences between males and females with LVDD, undergoing cardiac surgery. The investigators will look at perioperative factors such as body weight, body surface area, previous medical history, cardiac function measured by amongst others, transoesophageal echocardiography and haemodynamic parameters, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, inotropic requirements, risk, and outcome scores as well as complications, morbidity and mortality at 30 days. The investigators will evaluate these variables in an observational setting, with the goal of improving outcome in females after cardiac surgery in the future.
Read the detailed description
Cardiovascular disease is the leading cause of death among females in the Netherlands. According to the Netherlands Heart Registry (NHR), 25% more females than males died as a result of cardiovascular disease in 2019. In addition, females who undergo a cardiac surgery intervention have a higher risk of morbidity and mortality after cardiac surgery than males.
An important predictor and risk factor of adverse outcomes after cardiac surgery is the perioperative presence of heart failure (HF) with preserved ejection fraction (EF) (HFpEF).
HFpEF, also known as left ventricular diastolic dysfunction (LVDD), accounts for 30-50% of all patients presenting with symptoms of HF. Two-thirds of these patients are female.
The incidence of LVDD is generally increases with age. However, females are more likely to develop LVDD than males of the same age (ratio 2:1). Vascular stiffening is a crucial pathophysiological factor that contributes to the higher prevalence of LVDD in females. Females show a faster decline of ventricular elastance with age compared with males. Furthermore, several comorbidities contribute to a higher prevalence of LVDD in females: iron deficiency, diabetes, obesity, hypertension, preeclampsia, and autoimmune diseases. All are associated with the onset of an inflammatory response, which is considered as an important factor in the development of LVDD.
In diagnosing LVDD and determining its severity, echocardiography is of crucial value. Indeed, echocardiographic imaging allows LVDD to be classified into grades ranging from grade I (mild) to grade III (severe). In this regard, a higher grade is equivalent to a higher likelihood of symptomatic HF, and a worse prognosis. Transoesophageal echocardiography is the standard-of-care perioperative diagnostic intervention during cardiac surgery operations, to assess cardiac function. Intraoperatively, the simplified algorithm of Swaminathan et al., is used to assess diastolic function.
Several studies investigated sex-related differences in the outcomes of patients with LVDD, who were treated conservatively. These studies demonstrated that females with LVDD had similar outcomes of in-hospital and all-cause mortality compared with males. However, none of these studies focused on outcomes after cardiac surgery.
Additionally - despite known differences leading to higher morbidity and mortality in females after cardiac surgery - basic and clinical research has predominantly included male animals and male patients.
The aim of this study is to evaluate the differences between males and females with LVDD, undergoing cardiac surgery. We will look at perioperative factors such as body weight, body surface area, previous medical history, cardiac function measured by amongst others, transoesophageal echocardiography and haemodynamic parameters, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, inotropic requirements, risk, and outcome scores as well as complications, morbidity and mortality at 30 days. We will evaluate these variables in an observational setting, with the goal of improving outcome in females after cardiac surgery in the future.
We hypothesise that LVDD is more pronounced in female patients compared to male patients. Additionally, we hypothesise that females with LVDD (dependent on the grade of LVDD) have a poorer early outcome (≤30 days) after cardiac surgery than male patients.
- Conditions
- Left Sided Heart Failure
- Keywords
- sex-differences, left ventricular diastolic dysfunction, cardiac surgery, outcomes
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular diastolic dysfunction
number of patients with LVDD (grade I - III) before and after CPB. LVDD is measured by using the ratio of trans-mitral early flow velocity to early mitral annular tissue velocity (E/E')
Measured: Before statrt bypass and end of bypass
Secondary outcomes (1)
Composite endpoint
Composite endpoint: Mortality,Cerebrovascular accident (CVA), with persistent neurological disability, Acute kidney injury (AKI), as defined by KDIGO 2012,Low cardiac output syndrome (LCOS) with a vasoactive-inotropic score (VIS) > 45 or need for cardiac assist device,Pulmonary (and other) complications requiring ventilation >48 hours
Measured: measured 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Sep 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Sided Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 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, Jennifer Breel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Markus W Hollmann, Prof.Dr.Dr., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972356
- Sponsor's protocol ID
- W23_003#23.024
- Acronym
- EDISON
- Status last verified
- Feb 2026
- First submitted
- 24 Jul 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Left Ventricular DIastolic Dysfunction on Short Term Cardiac Surgery Outcomes in Female Cardiac patieNts
- ClinicalTrials.gov ID
- NCT05972356
- Acronym / sponsor ID
- EDISON / W23_003#23.024
- Conditions
- Left Sided Heart Failure
- Keywords
- sex-differences, left ventricular diastolic dysfunction, cardiac surgery, outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 2 Aug 2023 (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 aim of this study is to evaluate the differences between males and females with LVDD, undergoing cardiac surgery. The investigators will look at perioperative factors such as body weight, body surface area, previous medical history, cardiac function measured by amongst others, transoesophageal echocardiography and haemodynamic parameters, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, inotropic requirements, risk, and outcome scores as well as complications, morbidity and mortality at 30 days. The investigators will evaluate these variables in an observational setting, with the goal of improving outcome in females after cardiac surgery in the future.
Detailed description
Cardiovascular disease is the leading cause of death among females in the Netherlands. According to the Netherlands Heart Registry (NHR), 25% more females than males died as a result of cardiovascular disease in 2019. In addition, females who undergo a cardiac surgery intervention have a higher risk of morbidity and mortality after cardiac surgery than males.
An important predictor and risk factor of adverse outcomes after cardiac surgery is the perioperative presence of heart failure (HF) with preserved ejection fraction (EF) (HFpEF).
HFpEF, also known as left ventricular diastolic dysfunction (LVDD), accounts for 30-50% of all patients presenting with symptoms of HF. Two-thirds of these patients are female.
The incidence of LVDD is generally increases with age. However, females are more likely to develop LVDD than males of the same age (ratio 2:1). Vascular stiffening is a crucial pathophysiological factor that contributes to the higher prevalence of LVDD in females. Females show a faster decline of ventricular elastance with age compared with males. Furthermore, several comorbidities contribute to a higher prevalence of LVDD in females: iron deficiency, diabetes, obesity, hypertension, preeclampsia, and autoimmune diseases. All are associated with the onset of an inflammatory response, which is considered as an important factor in the development of LVDD.
In diagnosing LVDD and determining its severity, echocardiography is of crucial value. Indeed, echocardiographic imaging allows LVDD to be classified into grades ranging from grade I (mild) to grade III (severe). In this regard, a higher grade is equivalent to a higher likelihood of symptomatic HF, and a worse prognosis. Transoesophageal echocardiography is the standard-of-care perioperative diagnostic intervention during cardiac surgery operations, to assess cardiac function. Intraoperatively, the simplified algorithm of Swaminathan et al., is used to assess diastolic function.
Several studies investigated sex-related differences in the outcomes of patients with LVDD, who were treated conservatively. These studies demonstrated that females with LVDD had similar outcomes of in-hospital and all-cause mortality compared with males. However, none of these studies focused on outcomes after cardiac surgery.
Additionally - despite known differences leading to higher morbidity and mortality in females after cardiac surgery - basic and clinical research has predominantly included male animals and male patients.
The aim of this study is to evaluate the differences between males and females with LVDD, undergoing cardiac surgery. We will look at perioperative factors such as body weight, body surface area, previous medical history, cardiac function measured by amongst others, transoesophageal echocardiography and haemodynamic parameters, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, inotropic requirements, risk, and outcome scores as well as complications, morbidity and mortality at 30 days. We will evaluate these variables in an observational setting, with the goal of improving outcome in females after cardiac surgery in the future.
We hypothesise that LVDD is more pronounced in female patients compared to male patients. Additionally, we hypothesise that females with LVDD (dependent on the grade of LVDD) have a poorer early outcome (≤30 days) after cardiac surgery than male patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cardiac surgery will be asked for permission to use data collected as standard-of-care
Key inclusion criteria (1 listed)
- All patients >18 years, who undergo cardiac surgery from 1 January 2023 till 31 December 2026 in the Amsterdam UMC
Key exclusion criteria (1 listed)
- Patients who object to the re-use of their care data
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
Left ventricular diastolic dysfunction
Time frame: Before statrt bypass and end of bypass
number of patients with LVDD (grade I - III) before and after CPB. LVDD is measured by using the ratio of trans-mitral early flow velocity to early mitral annular tissue velocity (E/E')
1 secondary outcome
Composite endpoint
Time frame: measured 30 days after surgery
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 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Susanne Eberl, MD,PhD contact
Markus W Hollmann, Prof.Dr.Dr. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 Left Sided Heart Failure, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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: looking for participants now, as of the sponsor's last update on 17 Feb 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 Netherlands. 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 Jennifer Breel, MSc,PhD (+31(0)20 2566 2533, j.s.breel@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular diastolic dysfunction (time frame: Before statrt bypass and end of 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 17 Feb 2026.