Effect of Left Ventricle Diastolic Dysfunction on Outcomes in Female Cardiac Surgery Patients (EDISON)

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.

Study Overview

• Status: Recruiting
• Conditions: Left Sided Heart Failure

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Susanne Eberl, MD,PhD; Email: s.eberl@amsterdamumc.nl
• Study Contact Backup: Name: Jennifer Breel, MSc,PhD; Phone Number: +31(0)20 2566 2533; Email: j.s.breel@amsterdamumc.nl

Study Locations

• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1105AZ
      • Recruiting
      • Academic Medical Center
      • Contact: Susanne Eberl, MD,PhD; Phone Number: +31610019257; Email: s.eberl@amsterdamumc.nl
      • Contact: Jennifer S Breel, MSc, PhD; Phone Number: +31610019257; Email: j.s.breel@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing cardiac surgery will be asked for permission to use data collected as standard-of-care

Description

Inclusion Criteria:

• All patients >18 years, who undergo cardiac surgery from 1 January 2023 till 31 December 2026 in the Amsterdam UMC

Exclusion Criteria:

• Patients who object to the re-use of their care data

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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')	Before statrt bypass and end of bypass

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 30 days after surgery

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Markus W Hollmann, Prof.Dr.Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cardiac surgery; outcomes; left ventricular diastolic dysfunction; sex-differences
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Ventricular Dysfunction; Heart Failure; Ventricular Dysfunction, Left
• Other Study ID Numbers: W23_003#23.024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No