Our pilot study is designed to obtain data on sensitivity of g-cfDNA with the ddPCR technique to diagnose tissue rejection in heart transplant recipients, as determined by the golden standard EMB.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity: percentage of patients positive for rejection according to the
golden standard EMB that are also positive according to the ddPCR technique.
Secondary outcome
Not applicable.
Background summary
For heart transplantations acute rejections still occur at 15-30%. The golden
standard to diagnose is by collection of endomyocardial biopsies (EMBs) and
histologically evaluation for signs of rejection. These biopsies are performed
15 times a year per patient and consist of 5 heart tissue samples, thus adding
up to 75 tissue biopsies. This procedure is costly, highly inconvenient for the
patient and has the danger of complications (tricuspid valve damage, cardiac
tamponade, coronary fistula, rhythm disorders).No other diagnostic tool is
available to heart transplant rejection.
Study objective
Our pilot study is designed to obtain data on sensitivity of g-cfDNA with the
ddPCR technique to diagnose tissue rejection in heart transplant recipients, as
determined by the golden standard EMB.
Study design
Explorative prospective single center study
Study burden and risks
In our opionion there are no risks associated with participation in this study.
The additional vial of blood is drawn from a temporary sheet, which is already
required for EMB. Therefore no extra puncture is necessary for this study. The
hope is that in the future we can use g-cfDNA to reduce the amount of EMB. The
data will be prospectively collected and compared with the histological results
from the EMB. Standard of care will be based on the EMB and not influenced by
the outcome of the g-cfDNA.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Adult (*18 years) heart transplant patients
Exclusion criteria
No written informed consent
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 | NL60254.078.17 |