Sex differences in left ventricular diastolic dysfunction and outcomes after cardiac surgery
The Effect of Left Ventricular DIastolic Dysfunction on Short Term Cardiac Surgery Outcomes in Female Cardiac patieNts
This project will see if women with left ventricular diastolic dysfunction have different perioperative factors and 30-day outcomes than men when they undergo cardiac surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT05972356 on ClinicalTrials.gov |
What this trial studies
This is a single-center observational cohort using data from adults who had cardiac surgery at Amsterdam UMC between January 1, 2023 and December 31, 2026. Investigators will compare perioperative variables including body metrics, comorbidities, transesophageal echocardiography and hemodynamic measurements, transfusion and coagulation data, cardiopulmonary bypass factors, inotropic requirements, risk/outcome scores, and 30-day complications and mortality. Analyses will focus on differences between female and male patients with left ventricular diastolic dysfunction (LVDD/HFpEF) to identify patterns associated with worse outcomes in women. The overall aim is to identify actionable perioperative factors that could be targeted to improve outcomes for female cardiac surgery patients.
Who should consider this trial
Good fit: Adults over 18 who underwent cardiac surgery at Amsterdam UMC between January 1, 2023 and December 31, 2026 and who do not object to reuse of their care data are eligible.
Not a fit: Patients who object to reuse of their care data or who had surgery outside Amsterdam UMC during the study period will not be included and therefore will not benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help tailor perioperative care to reduce complications and deaths in women undergoing cardiac surgery.
How similar studies have performed: Previous observational work has identified sex-related differences in HFpEF and surgical outcomes, but few large perioperative datasets have specifically examined LV diastolic dysfunction in female cardiac surgery patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amsterdam, North Holland
- Academic Medical Center — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Markus W Hollmann, Prof.Dr.Dr. — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study coordinator: Jennifer Breel, MSc,PhD
- Email: j.s.breel@amsterdamumc.nl
- Phone: +31(0)20 2566 2533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.