Quantifying the viral persistence and related inflammation in normal hearts versus idiopathic, ischemic, hypertensive and familial cardiomyopathie.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparing the degree of viral presence between the different groups using PCR
analysis of the biopsies.
Secondary outcome
Additional analysis of the type/degree of inflammation in the myocardium using
histological and immunohistological examination.
Background summary
Viral persistence is increasingly being recognized as an important factor in
acute and chronic heart failure. The present study is to further investigate
the prevalence of virus persistence and related inflammation in idiopathic
cardiomyopathy (CMP), heart failure of unknown origin. We will investigate
whether viral presence may aggravate heart failure caused by hypertensive,
ischemic, valvular or familial CMP.
Study objective
Quantifying the viral persistence and related inflammation in normal hearts
versus idiopathic, ischemic, hypertensive and familial cardiomyopathie.
Study design
This is a cross-sectional analysis of virus presence and viral load between the
different groups.
Cardiac biopsies are collected and analysed from 40 patients within each group
(160 total) either during planned cardiao-thoracic surgery or during the
coronary angiogram including diagnostic biopsies as routine diagnostic work-up
for idiopathic cardiomyopathie.
Furthermore additional blood (30ml) will be collected for future research in
the line of this project.
Study burden and risks
Three transmural biopsies will be obtained during elective cardiac surgery for
coronary or valvular CMP. This is a very safe procedure, with a very low risk
(<1 %) of peri-operative complications. Arrhythmias, perforation and
post-operative bleeding is prevented by placing a stitch at the place of biopsy
taking. Post-operative complications with this procedure has never been
described.
Seven diagnostic endomyocardial right ventricular biopsies are taken in
patients with idiopathic dilated cardiomyopathy, as part of a routine
diagnostic work-up. Here, patients with a prior history of arrhythmias may have
the rhythm exacerbated by endocardial irritation. Pericardial bleeding as a
consequence of right ventricular perforation occurs in about 0.5%, requiring
pericardial drainage in 50%.
The amount of extra blood taken is minor (30ml) that no complications are
expected.
P.Debeyelaan 25
6229 HX Maastricht
NL
P.Debeyelaan 25
6229 HX Maastricht
NL
Listed location countries
Age
Inclusion criteria
Patients with idiopathic heartfailure undergoing routine analysis (including cardiac biopsies).
Patients with or without heartfailure undergoing elective cardio-thoracic surgery.
Exclusion criteria
Emergency cardiothoracic surgery
Pregnancy or lactation
Design
Recruitment
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 | NL17724.068.07 |