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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Jennifer Breel, MSc,PhD contact

+31(0)20 2566 2533

j.s.breel@amsterdamumc.nl

Susanne Eberl, MD,PhD contact

s.eberl@amsterdamumc.nl

Netherlands1 site, 1 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

    Recruiting

Other trials in Netherlands

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.

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.

  1. 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)
  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.

  1. First posted2 Aug 2023
  2. Study start1 Sep 2025
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

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)
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

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.

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