Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05972356 |
| Other study ID # |
W23_003#23.024 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 25, 2023 |
| Est. completion date |
July 25, 2027 |
Study information
| Verified date |
July 2023 |
| Source |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Contact |
Jennifer Breel, MSc |
| Phone |
+31(0)20 2566 2533 |
| Email |
j.s.breel[@]amsterdamumc.nl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
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.1
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.2 Two-thirds of these patients are female.3 The
incidence of LVDD is generally increases with age.4 However, females are more likely to
develop LVDD than males of the same age (ratio 2:1).5 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.6
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.6
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.,8
is used to assess diastolic function.
Several studies investigated sex-related differences in the outcomes of patients with LVDD,
who were treated conservatively. 9-12 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.
