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
1 other identifier
observational
1,000
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2023
CompletedFirst Posted
Study publicly available on registry
August 2, 2023
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
February 17, 2026
February 1, 2026
1 year
July 24, 2023
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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')
Before statrt bypass and end of bypass
Secondary Outcomes (1)
Composite endpoint
measured 30 days after surgery
Eligibility Criteria
Adult patients undergoing cardiac surgery will be asked for permission to use data collected as standard-of-care
You may qualify if:
- All patients \>18 years, who undergo cardiac surgery from 1 January 2023 till 31 December 2026 in the Amsterdam UMC
You may not qualify if:
- Patients who object to the re-use of their care data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academic Medical Center
Amsterdam, North Holland, 1105AZ, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Markus W Hollmann, Prof.Dr.Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Epidemiologist
Study Record Dates
First Submitted
July 24, 2023
First Posted
August 2, 2023
Study Start
September 1, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02