To assess the inflammatory secretome of EAT, its subsequent interaction with cardiomyocytes, and its potential implication in the development of LV diastolic dysfunction.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are EAT-mediated inflammatory biomarkers and their
association with clinical parameters for HFpEF, as well as their interaction
with cardiomyocyte/endothelium structure and/or function.
Secondary outcome
The secondary study paramaters are:
- Differences in inflammatory markers between EAT and subcutaneous adipose
tissue (EAT) samples and secretomes
- Inflammatory biomarkers in plasma and the different with nflammatory
biomarkers in EAT samples
Background summary
The incidence of heart failure with preserved ejection fraction (HFpEF)
continues to rise at an alarming rate, and to date effective treatments are
severely limited. Patients with HFpEF suffer from high morbidity and mortality
due to left ventricular (LV) diastolic dysfunction with consequently increased
filling pressures of the heart. Additionally, most patients suffer from
comorbidities such as hypertension, metabolic disease, and obesity.
Obesity has been identified as a key player in the pathophysiology of HFpEF.
Multiple studies have demonstrated a strong correlation between accumulation of
epicardial adipose tissue (EAT) and worse clinical outcomes. Furthermore, EAT
is suggested to drive structural and functional impairments of the myocardium,
mainly through activation of inflammatory pathways.
Study objective
To assess the inflammatory secretome of EAT, its subsequent interaction with
cardiomyocytes, and its potential implication in the development of LV
diastolic dysfunction.
Study design
Observational study
Study burden and risks
EAT and subcutaneous adipose tissue (SAT) that are retrieved during elective
cardiac (open-heart) surgery anyway, will be collected. EAT is normally removed
from different locations (e.g. ventricular free wall, right atrial appendage)
to improve access to the heart and/or coronary arteries during the surgery.
Additionally, the surgeon typically removes some SAT at the site of incision to
facilitate access to the heart. In both situations, EAT and SAT are normally
disposed of as surgical waste. For this study, we would like to use the already
retrieved EAT and SAT for further processing. Since the tissue is separated and
collected anyway as part of the procedure, there are no additional risks
involved.
Additionally, we would like to collect some extra blood samples during routine
blood collection prior to the surgery
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- Patients undergoing elective cardiac surgery with cardiopulmonary bypass
- Legally competent, willing, and able to sign informed consent
Exclusion criteria
- Hemodynamically stable, no inotropic/vasopressic and/or mechanical support
prior to surgery.
- Active infection or inflammation, e.g. endocarditis, pericarditis
- Chronic use of anti-inflammatory medication, e.g. steroids;
- Age <18 years
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85954.018.23 |