Early detection and prediction of cardiotoxicity in chemotherapy-treated patients with the use of the new high sensitivity troponin t assay.
ID
Source
Brief title
Condition
- Heart failures
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Relation between hs-TNT values and cardiac dysfunction (measured by left
ventricular ejection fraction with echocardiography) after chemotherapy.
Secondary outcome
Secondary objectives of this study are to investigate the relation between the
change in hs-TNT values and cardiac function after Ctx.
1. hs-TNT kinetics during Ctx and relation to cardiac function (% LVEF). (delta
change within one Ctx cycle, delta change between Ctx cycles, delta change
baseline and final hs-TNT value)
2. Detection and prediction of cardiotoxicity (definition: an asymptomatic
reduction >10% of the LVEF reaching ,<55%, or a symptomatic reduction >5% of
the LVEF reaching <55%) by hs-TNT values (single value or delta changes).
Background summary
Cardiotoxicity is a serious adverse effect of anticancer drugs, impacting on
quality of life and overall survival of cancer patients. Currently, there is
increasing evidence that patients previously treated with chemotherapy have an
increased cardiovascular risk, with a mortality rate that is about eight-fold
that of the general population.
At present, the most frequently used modality for detecting cardiotoxicity is
the evaluation of symptoms suggestive ofheart failure, combined with the
periodic non-invasive measurement of left ventricular ejection fraction (LVEF).
The current approach includes assessment of baseline cardiac function, before
starting CT, and a cardiac surveillance during and after its completion, by the
evaluation of LVEF using either echocardiography or multigated acquisition
scanning. No consensus- or evidence-based guidelines regarding the cardiac
surveillance of cancer patients yet exist. As a consequence, no systematic
evaluation for cardiac dysfunction in asymptomatic survivors of cancer is
performed, although cardiac morbidity can become apparent even several years
after treatment. The most critical limitation of the present approach
is that LVEF measurement is a relatively insensitive tool for detecting
CT-induced cardiotoxicity at an early stage. This is largely because no
considerable change in systolic function occurs until a critical amount of
myocardial damage has taken place. Indeed, the weak point is that cardiac
damage is usually detected only when a functional impairment has already
occurred, precluding any chance of preventing its
development. When chemotherapy-induced cardiomyopathy develops, complete
recovery of cardiac function occurs inonly 42% of patients, despite optimal
pharmacologic therapy.
Study objective
Early detection and prediction of cardiotoxicity in chemotherapy-treated
patients with the use of the new high sensitivity troponin t assay.
Study design
This is an observational study, where hs-TNT levels will be measured before,
during and after treatment with chemotherapy. The relation of hs-TNT values
with cardiac function (measured by echocardiography) will be assessed.
Study burden and risks
Total burden for the patients is 14 venapunctures and 2 times echocardiography.
de run 4600
VELDHOVEN 5504 DB
NL
de run 4600
VELDHOVEN 5504 DB
NL
Listed location countries
Age
Inclusion criteria
-Female breast cancer patients
-Age between 30-60 years
-18-weeks of chemotherapy-treatment, adjuvant or neo-adjuvant
-Chemotherapy may include: (AC) adriamycin/cyclophosphamide, (FEC) fluorouracil/epiribicin/cyclophosphamide, (TAC) taxotere/ adriamycin/cyclophosphamide
-Ejection fraction > 50%
Exclusion criteria
-Ejection fraction <50%
-previous signs of cardiovascular disease
-kidney dysfunction (eGFR <60 ml/min/1,73m^2).
-previous treatment with anthracyclines
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 | NL40403.015.12 |